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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 65459

30 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
June 07, 2013
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Biomet, Inc.

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

30 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 30

REF 154200 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1695-2013
Recall number
Z-1695-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M619730 , M480920, M656920, M938460, M444630

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 2 of 30

REF 154201 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1696-2013
Recall number
Z-1696-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
22

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M619740, M492940, M444640, M656930, M938470

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 3 of 30

REF 154202 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1697-2013
Recall number
Z-1697-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
28

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M879630 , M584360, M492950, M444650, M656940, M938480

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 4 of 30

REF 154203 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1698-2013
Recall number
Z-1698-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M879640, M375460, M444660, M886350, M938490

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 5 of 30

REF 154204 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size A7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1699-2013
Recall number
Z-1699-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
22

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M375470, M444680 , M886360, M938500

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 6 of 30

REF 154207 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1700-2013
Recall number
Z-1700-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M561220 M584370 M151880 , M444690, M886370 , M956050,

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 7 of 30

REF 154208 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1701-2013
Recall number
Z-1701-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
24

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M619750 ; M375480; M886380, M956060 , M444700

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 8 of 30

REF 154209 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1702-2013
Recall number
Z-1702-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
23

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M561290, M956070, M444710 6, M136780, M886390

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 9 of 30

REF 154210 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size 6ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1703-2013
Recall number
Z-1703-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
22

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M375490, M444720 , M886400, M956080

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 10 of 30

REF 154211 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size B7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1704-2013
Recall number
Z-1704-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
22

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M375500 ,M886410, M444760, M956090

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 11 of 30

REF 154214 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1705-2013
Recall number
Z-1705-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
32

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M321570, M894590,M619770, M480930, M656950 M444780, M969100

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 12 of 30

REF 154215 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1706-2013
Recall number
Z-1706-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
30

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M321580 , M619780, M492960, M656960, M969120 , M444790 6

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 13 of 30

REF 154216 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1707-2013
Recall number
Z-1707-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
23

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M539400, M619790, M987360 , M444800, M969130, M151150, M987360

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 14 of 30

REF 154217 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1708-2013
Recall number
Z-1708-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
24

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M492970, M598310, M598310, M656980, M969150

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 15 of 30

REF 154218 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size C7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1709-2013
Recall number
Z-1709-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
20

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M584380, M754830, M969160, M444820, M987510

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 16 of 30

REF 154221 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1710-2013
Recall number
Z-1710-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
29

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M987290, M035670, 987410, M444830, M920680, M754840

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 17 of 30

REF 154222 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1711-2013
Recall number
Z-1711-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
37

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M598320, M480940, M987300, M444840, M656990

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 18 of 30

REF 154223 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1712-2013
Recall number
Z-1712-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
46

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M300790, M632920, M539410, M444850, M987620, M987310

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 19 of 30

REF 154224 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1713-2013
Recall number
Z-1713-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M632930 , M539420 , M444860 , M657010, M987630 , M987320

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 20 of 30

REF 154225Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size D7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1714-2013
Recall number
Z-1714-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 21 of 30

REF 154228 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1715-2013
Recall number
Z-1715-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M619800 , M106200, M444870 , M657020 , M987640 , M987330 , M987640

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 22 of 30

REF 154229 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1716-2013
Recall number
Z-1716-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M561240, M632960 , M136950 M657040 , M722420 , M444890

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 23 of 30

REF 154230 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1717-2013
Recall number
Z-1717-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M480950 , M657050, M444900 , M030220

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 24 of 30

REF 154231Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1718-2013
Recall number
Z-1718-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
28

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M321600, M539430, M444910, M657070,M722440, M136980, M444910

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 25 of 30

REF 154232 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size E7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1719-2013
Recall number
Z-1719-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
31

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M921180, M539440, M444920, M722450, M136990, M657080

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 26 of 30

REF 154235Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F3 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1720-2013
Recall number
Z-1720-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
26

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M632970 , M539450 , M920610 , M657090 , M017520 , M166860 , M886420

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 27 of 30

REF 154236 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F4 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee.The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1721-2013
Recall number
Z-1721-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M632980 , M539460 , M657100 , M017530 , M166870 , M920620 , M886430

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 28 of 30

REF 154237 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F5 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1722-2013
Recall number
Z-1722-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
23

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M561250, M657110, M017540, M166880, M920640, M886440

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 29 of 30

REF 154238 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F6 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1723-2013
Recall number
Z-1723-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
25

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M480960, M657120, M886450, M166890, M920650

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

device · product 30 of 30

REF 154239 Oxford Fixed Bearing Partial Knee Cemented Lateral Tibia Size F7 ARCOM UHMWPE / CO-CR-MO Alloy Only for use in Lateral compartment Sterile R The Oxford Fixed Bearing Knee is a Partial knee replacement system consisting of a femoral component and a fixed bearing tibial component for use in the lateral compartment of the knee. The Oxford Fixed Lateral bearings are indicated for use in the lateral compartment and intended to be implemented with bone cement.

Z-1724-2013
Recall number
Z-1724-2013
Initiated
June 07, 2013
Classification
Class II
Status
Terminated
Recalling firm
Biomet, Inc.
Quantity
24

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Device Design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

Biomet investigation found the design of the tibial bearing creates the potential for anterior impingement between the bone and the poly bearing component in terminal extension.

Code information

M492980, M657130, M920670, M886460, M166900

Distribution pattern

Worldwide distribution: USA including NC, IN, PA, and OH; and countries of: Canada and Netherlands.

Field note

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