Exactech, Inc. Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY***EXACTECH Gainesville, FL 32653***. '' Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in part: ''OPTETRAK FINNED TIBIAL TRAY A/P53 mm M/L 83mm***STERILE, SINGLE USE ONLY FOR CEMENTED USE ONLY***EXACTECH Gainesville, FL 32653***. ''
Brand
Exactech, Inc.
Lot Codes / Batch Numbers
Catalogue number 200-04-45, Serial number range 0730621-07306351, Lot number 452500.
Products Sold
Catalogue number 200-04-45; Serial number range 0730621-07306351; Lot number 452500.
Exactech, Inc. is recalling Product is Optetrak Cemented Finned Tibial Tray Sz. 4F/5T. Knee prosthesis. Product is labeled in due to An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not . Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
An implant within a lot of finned tibial trays manufactured at Exactech was not made to specification. The locking cavity in the tibial tray was not fully machined thus preventing the tibial insert from locking in place.
Recommended Action
Per FDA guidance
Each consignee contacted by mail 12/19/2005, and asked to return the product to Exactech. The returned product will be quarantined and evaluated.
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 noticeDistribution
As reported by FDA
AL, LA
Page updated: Jan 10, 2026