Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint… recallZ-0347-05 · Exactech, Inc. · initiated Nov 11, 2004
Terminated All recalls posted in December 2004
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
Implant was identified incorrectly at the time of manufacture and was then labeled and distributed with the incorrect size information.
FDA root cause category: Other
What the company is doing
A recall letter was sent to all customers on November, 2, 2004 recalling all 21 units. These implants will be quarantined and then returned to the supplier for disposal when all 21 implants are received.
Recall details
- Recall number
- Z-0347-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 11, 2004
- Posted by the FDA
- Dec 23, 2004
- Recalling firm
- Exactech, Inc.
- Quantity
- 21 implants
- Product code
- JWH
- FDA submissions
- K933610
- Distribution
- Distributed to New Jersey, Florida, Minnesota, New York, Maryland, Texas and the United Kingdom
Product description
Cemented Trapezoid Tibial Tray Sz. 4F/4T, Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.
Code information (models, lots, serial numbers)
Serial numbers 0638851-0638871
Other devices under the same FDA submission
71 devices cleared under K933610 — 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 204-21-13Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls1 report
- Optetrak 204-22-26Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer2 recalls0 reports
- Optetrak 204-24-09Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall38 reports
- Optetrak 204-23-09Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall37 reports
- Optetrak 204-23-11Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall26 reports
- Optetrak 204-24-11Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall25 reports
- Optetrak 204-22-09Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall21 reports
- Optetrak 204-22-11Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall19 reports
- Optetrak 204-24-13Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall14 reports
- Optetrak 204-22-13Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall13 reports
- Optetrak 204-25-09Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall13 reports
- Optetrak 204-23-13Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 recall10 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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