Exactech, Inc. 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***''. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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***''.
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
Serial number range 0696020 - 0696061.
Products Sold
Serial number range 0696020 - 0696061.
Exactech, Inc. is recalling The product is a Finned Tibial Tray. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P due to Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.
Recommended Action
Per FDA guidance
All consignees were notified by letter on 06/02/2005.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026