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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 78111

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

Open FDA event record

Event summary

Timeline bucket
September 19, 2017
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Exactech, 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

34 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 34

Optetrak Offset Tibial Tray and Screws, Size 0F/0T, Alpha, Ref 208-04-01, Sterile, RX.

Z-0126-2018
Recall number
Z-0126-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
57 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 2 of 34

Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Alpha, Ref 208-04-11, Sterile, RX.

Z-0127-2018
Recall number
Z-0127-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
109 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 3 of 34

Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/0T, Beta, Ref 208-04-12, Sterile, RX.

Z-0128-2018
Recall number
Z-0128-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
114 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 4 of 34

Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Alpha, Ref 208-04-13, Sterile, RX.

Z-0129-2018
Recall number
Z-0129-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
198 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 5 of 34

Optetrak Offset Tibial Tray and Screws, Size 1DeltaF/1T, Beta, Ref 208-04-14, Sterile, RX.

Z-0130-2018
Recall number
Z-0130-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
207 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 6 of 34

Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Alpha, Ref 208-04-21, Sterile, RX.

Z-0131-2018
Recall number
Z-0131-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
640 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 7 of 34

Optetrak Offset Tibial Tray and Screws, Size 1F/1T & 2F/1T, Beta, Ref 208-04-22, Sterile, RX.

Z-0132-2018
Recall number
Z-0132-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
665 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 8 of 34

Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Alpha, Ref 208-04-23, Sterile, RX.

Z-0133-2018
Recall number
Z-0133-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
801 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 9 of 34

Optetrak Offset Tibial Tray and Screws, Size 1F/2T & 2F/2T, Beta, Ref 208-04-24, Sterile, RX.

Z-0134-2018
Recall number
Z-0134-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
893 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 10 of 34

Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Alpha, Ref 208-04-31, Sterile, RX.

Z-0135-2018
Recall number
Z-0135-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
733 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 11 of 34

Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Alpha, Ref 208-04-33, Sterile, RX.

Z-0136-2018
Recall number
Z-0136-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
683 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 12 of 34

Optetrak Offset Tibial Tray and Screws, Size 3F/3T, Beta, Ref 208-04-34, Sterile, RX.

Z-0137-2018
Recall number
Z-0137-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
720 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 13 of 34

Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Alpha, Ref 208-04-41, Sterile, RX.

Z-0138-2018
Recall number
Z-0138-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
527 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 14 of 34

Optetrak Offset Tibial Tray and Screws, Size 4F/3T, Beta, Ref 208-04-42, Sterile, RX.

Z-0139-2018
Recall number
Z-0139-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
573 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 15 of 34

Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Alpha, Ref 208-04-43, Sterile, RX.

Z-0140-2018
Recall number
Z-0140-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
547 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 16 of 34

Optetrak Offset Tibial Tray and Screws, Size 4F/4T, Beta, Ref 208-04-44, Sterile, RX. .

Z-0141-2018
Recall number
Z-0141-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
537 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 17 of 34

Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Alpha, Ref 208-04-51, Sterile, RX.

Z-0142-2018
Recall number
Z-0142-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
311 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 18 of 34

Optetrak Offset Tibial Tray and Screws, Size 5F/4T, Beta, Ref 208-04-52, Sterile, RX.

Z-0143-2018
Recall number
Z-0143-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
333 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 19 of 34

Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Alpha, Ref 208-04-53, Sterile, RX.

Z-0144-2018
Recall number
Z-0144-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
317 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 20 of 34

Optetrak Offset Tibial Tray and Screws, Size 5F/5T, Beta, Ref 208-04-54, Sterile, RX.

Z-0145-2018
Recall number
Z-0145-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
306 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 21 of 34

Optetrak Constrained Condylar Offset Screw, Size AA, Ref 208-04-70, Sterile, RX. .

Z-0146-2018
Recall number
Z-0146-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
643 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 22 of 34

Optetrak Constrained Condylar Offset Screw, Size BB, Ref 208-04-71, Sterile, RX.

Z-0147-2018
Recall number
Z-0147-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
840 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 23 of 34

Optetrak Constrained Condylar Offset Screw, Size DD, Ref 208-04-72, Sterile, RX.

Z-0148-2018
Recall number
Z-0148-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
889 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 24 of 34

Optetrak Constrained Condylar Offset Screw, Size EE, Ref 208-04-73, Sterile, RX.

Z-0149-2018
Recall number
Z-0149-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
920 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 25 of 34

Optetrak Constrained Condylar Offset Screw, Size FF, Ref 208-04-74, Sterile, RX.

Z-0150-2018
Recall number
Z-0150-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
953 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 26 of 34

Optetrak Constrained Condylar Offset Screw, Size GG, Ref 208-04-75, Sterile, RX.

Z-0151-2018
Recall number
Z-0151-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
895 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 27 of 34

Optetrak Constrained Condylar Offset Screw, Size HH, Ref 208-04-76, Sterile, RX.

Z-0152-2018
Recall number
Z-0152-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
606 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 28 of 34

Optetrak Constrained Condylar Offset Screw, Size JJ, Ref 208-04-77, Sterile, RX.

Z-0153-2018
Recall number
Z-0153-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
656 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 29 of 34

Optetrak Constrained Condylar Offset Screw, Size KK, Ref 208-04-78, Sterile, RX.

Z-0154-2018
Recall number
Z-0154-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
575 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 30 of 34

Optetrak Constrained Condylar Offset Screw, Size LL, Ref 208-04-79, Sterile, RX.

Z-0155-2018
Recall number
Z-0155-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
537 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 31 of 34

Optetrak Constrained Condylar Offset Screw, Size MM, Ref 208-04-80, Sterile, RX.

Z-0156-2018
Recall number
Z-0156-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
520 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 32 of 34

Optetrak Constrained Condylar Offset Screw, Size PP, Ref 208-04-81, Sterile, RX.

Z-0157-2018
Recall number
Z-0157-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
386 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 33 of 34

Optetrak Constrained Condylar Offset Screw, Size RR, Ref 208-04-82, Sterile, RX.

Z-0158-2018
Recall number
Z-0158-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
411 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

device · product 34 of 34

Optetrak Offset Tibial Tray and Screws, Size 3F/2T, Beta, Ref 208-04-32, Sterile, RX.

Z-0159-2018
Recall number
Z-0159-2018
Initiated
September 19, 2017
Classification
Class II
Status
Terminated
Recalling firm
Exactech, Inc.
Quantity
678 devices

App-derived interpretation

Device software or design reason.device_software_design · v1.0.0
design incompatibility

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Labeling design

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

There is a design incompatibility between certain sizes of the offset spine stiffener screw and the constrained condylar tibial insert when used in conjunction with an offset tibial tray.

Code information

All lot numbers

Distribution pattern

Distribution was made to AL, FL, IN, ME, MN, NJ, NY, OH, OK, VA, and Puerto Rico. Foreign distribution was made to Argentina, Australia, Brazil, China, Colombia, France, India, Italy, Luxembourg, The Netherlands, Spain, Switzerland, Tunisia, and United Kingdom.

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