BEUDAMED
    FDA Recall Terminated

    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: Z-0927-06 · Initiated December 19, 2005

    Recall

    Recall Number
    Z-0927-06
    Event Number
    34294
    Firm
    Exactech, Inc.
    FEI Number
    1038671
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 19, 2005
    Posted
    June 2, 2006
    Terminated
    June 29, 2012
    Address
    2320 NW 66th Ct, Gainesville, FL, 32653-1630

    Description

    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***. ''

    Reason

    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.

    Action

    Each consignee contacted by mail 12/19/2005, and asked to return the product to Exactech. The returned product will be quarantined and evaluated.

    Distribution

    Distributed domestically to Alabama and Louisiana, and internationally to Spain, Germany and Greece.

    Quantity

    14 implants from manufactured lot