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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 73609

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

Open FDA event record

Event summary

Timeline bucket
March 11, 2016
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Smith & Nephew, 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

15 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 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 2 LEFT, STERILE R, REF 12 000 002, S&N 7500257, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1537-2016
Recall number
Z-1537-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
2 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch Number C1507852

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 2 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 005, S&N 7500260, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1538-2016
Recall number
Z-1538-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch number C1507158

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 3 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 10 LEFT, STERILE R, REF 12 000 006, S&N 7500261, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1539-2016
Recall number
Z-1539-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
3 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch number C1507675

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 4 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 2 RIGHT, STERILE R, REF 12 000 009, S&N 7500264, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1540-2016
Recall number
Z-1540-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch number C1507853

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 5 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 0011, S&N 7500266, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1541-2016
Recall number
Z-1541-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
4 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch number C1507159

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 6 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 0012, S&N 7500267, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1542-2016
Recall number
Z-1542-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch number C1507672

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 7 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 0013, S&N 7500268, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1543-2016
Recall number
Z-1543-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch number C1507674

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 8 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 4 LEFT, STERILE R, REF 12 000 017, S&N 7500272, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1544-2016
Recall number
Z-1544-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
24 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch numbers: B1508762, B1504644, B1500721

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 9 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 6 LEFT, STERILE R, REF 12 000 018, S&N 7500273, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1545-2016
Recall number
Z-1545-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
22 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch numbers: B1510531, B1506602, B1502407

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 10 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Left, SIZE 8 LEFT, STERILE R, REF 12 000 019, S&N 7500274, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1546-2016
Recall number
Z-1546-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
15 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch numbers: B1506274, B1501722

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 11 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 4 RIGHT, STERILE R, REF 12 000 024, S&N 7500279, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1547-2016
Recall number
Z-1547-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch numbers: B1512224, B1509601, B1506853, B1501435, B1500308

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 12 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 6 RIGHT, STERILE R, REF 12 000 025, S&N 7500280, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1548-2016
Recall number
Z-1548-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
33 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch numbers: B1500308, B1504018, B1500952

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 13 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 8 RIGHT, STERILE R, REF 12 000 026, S&N 7500281, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1549-2016
Recall number
Z-1549-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
34 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch numbers: B1514883, B1509344, B1504926, B1502141,

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 14 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 10 RIGHT, STERILE R, REF 12 000 027, S&N 7500282, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1550-2016
Recall number
Z-1550-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
1 unit

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch number B1505699

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

device · product 15 of 15

TC-PLUS(TM), Primary Fixed Tibial Component VKS Right, SIZE 12 RIGHT, STERILE R, REF 12 000 028, S&N 7500283, Smith & Nephew Orthopaedics AG Product Usage: Tibial knee prosthesis

Z-1551-2016
Recall number
Z-1551-2016
Initiated
March 11, 2016
Classification
Class II
Status
Terminated
Recalling firm
Smith & Nephew, Inc.
Quantity
6 units

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Process control

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

The Affected Devices may contain a dimensional deviation that could potentially result in the surgeon being unable to seat the polyethylene (PE) Insert on the affected VKS tibial base plate during surgery.

Code information

Batch numbers: B1509884, B1503362

Distribution pattern

International Distribution only in countries of: Germany and Switzerland.

Field note

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