Optetrak Logic Comprehensive Knee Prosthesis System… recallZ-0953-2013 · Exactech, Inc. · initiated Feb 1, 2013
Class II Terminated All recalls posted in March 2013
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
A dimensional mismatch was identified which can potentially allow for interference between devices.
FDA root cause category: Device Design
What the company is doing
Exactech Inc. sent a *** Important *** Product Market Recall Notice dated January 30, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. 1. Customers were instructed to immediately cease distribution or use of these products. 2. Extend this information to your accounts that may have this product in their possession. 3. Verify if you have any of the subject Optetrak Logic Proxima Tibial Spacer (PTS) in the specified lots. Please complete the attached fax back form and return it to Exactech within the next 5 working days. Thank you for your prompt attention to this matter. For further questions please call (352) 377-1140.
Recall details
- Recall number
- Z-0953-2013
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 1, 2013
- Posted by the FDA
- Mar 15, 2013
- Recalling firm
- Exactech, Inc.
- Quantity
- 123 devices
- Product code
- JWH
- FDA submissions
- K071738
- Distribution
- Nationwide Distribution including the states of FL, AL, LA, PA, VA, IL, OH, NY, NC, KS, TN, NJ, CO, GA, CA, MD, MN, IN, & Puerto Rico.
Product description
Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
Code information (models, lots, serial numbers)
Catalog # 02-012-42-3508 All lot numbers
Other devices under the same FDA submission
3 devices cleared under K071738 — 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 Logic 02-012-42-2508Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Optetrak Logic 02-012-42-3008Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
- Optetrak Logic 02-012-42-5008Exactech, Inc. · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer1 report
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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