Optetrak Logic Comprehensive Knee Prosthesis System, Proximal Tibial Spacer and screws, size 3.5, 8mm, Catalog # 02-012-42-3508.
FDA Recall Z-0953-2013 · Posted 2013-03-15
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Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2013-02-01
Date Terminated2014-09-22
Product Quantity123 devices
Reason for Recall
A dimensional mismatch was identified which can potentially allow for interference between devices.
Firm Action
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.
Root Cause
Device Design
Distribution Pattern
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.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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