Polyethylene tibial posterior stabilized components.… recallZ-0522-2007 · Exactech, Inc. · initiated Dec 7, 2006
Terminated All recalls posted in February 2007
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Exactech, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The outside profile on this manufactured lot of devices is oversized and does not meet specifications.
FDA root cause category: Other
What the company is doing
Letter dated 12/08/06. The firm representative retrieved all four devices from the field.
Recall details
- Recall number
- Z-0522-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Dec 7, 2006
- Posted by the FDA
- Feb 27, 2007
- Recalling firm
- Exactech, Inc.
- Quantity
- 4 units
- Product code
- JWH
- FDA submissions
- K933494
- Distribution
- Distributed to one hospital in New York.
Product description
Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
Code information (models, lots, serial numbers)
serial numbers: 0900529-0900532
Other devices under the same FDA submission
21 devices cleared under K933494 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Optetrak 204-13-13Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall4 reports
- Optetrak 204-14-11Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak 204-14-13Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall2 reports
- Optetrak 204-11-13Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 report
- Optetrak 204-12-11Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 report
- Optetrak 204-12-13Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 report
- Optetrak 204-13-09Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 report
- Optetrak 204-13-11Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 report
- Optetrak 204-14-09Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 report
- Optetrak 204-16-13Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall1 report
- Optetrak 204-11-09Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall0 reports
- Optetrak 204-11-11Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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