BEUDAMED
    FDA Recall Terminated

    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: Z-1379-05 · Initiated June 2, 2005

    Recall

    Recall Number
    Z-1379-05
    Event Number
    32568
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 2, 2005
    Posted
    August 18, 2005
    Terminated
    October 24, 2008
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    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***''.

    Reason

    Implant was identified incorrectly at the time of manufacture and then laser etched with the incorrect size information.

    Action

    All consignees were notified by letter on 06/02/2005.

    Distribution

    Distributed to 15 Domestic Consignees 4 Foreign Distributors.

    Quantity

    41