The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P 53 mm ML 83mm***4F/5T Ti Alloy FITS ONLY SZ. 4 FEMORAL CEMENTED***STERILE, SINGLE USE ONLY. FOR CEMENTED USE ONLY***''.
FDA Recall Z-1379-05 · Posted 2005-08-18
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Recalling FirmExactech, Inc.
Recall StatusTerminated
Product CodeJWH
Date Initiated2005-06-02
Date Terminated2008-10-24
Product Quantity41
Reason for Recall
Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.
Firm Action
All consignees were notified by letter on 06/02/2005.
Root Cause
Other
Distribution Pattern
Distributed to 15 Domestic Consignees 4 Foreign Distributors.
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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