BEUDAMED
    FDA Recall Terminated

    Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.

    Recall: Z-1043-2015 · Initiated December 15, 2014

    Recall

    Recall Number
    Z-1043-2015
    Event Number
    70100
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 15, 2014
    Posted
    February 3, 2015
    Terminated
    September 22, 2016
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Trident PSL HA Solid Back 50 mm Includes Dome Hole Plug Ref 540-11-50E Intended for cementless application in a total hip arthroplasty procedure. This system is a two piece ( a shell and a liner) design that is assembled during surgery. The shell is press-fit into the patients prepared acetabulum and a linger (polyethylene or alumina ceramic) is then locked into the shell. The femoral head component of the total hip system articulates with the acetabular liner.

    Reason

    Five customer complaints were received for the same batch of Trident PSL Shells (part number 540-11-50E lot 49073501) alleging that when the packages were opened there were no dome holes plugs present.

    Action

    Stryker sent an Urgent Medical Device letter dated January 7, 2015, with a Recall Notification/Acknowledgement Form via Fed Ex to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to complete and return the attached Product Recall Acknowledgement Form to [email protected] or fax to 1-855-251-3635. Customers should return the affected product to: Attention: Regulatory Compliance Stryker Orthopaedics 325 Corporate Drive Mahwah, New Jersey 07430 Customers with questions should call 201-831-6365. For questions regarding this recall call 201-831-5000.

    Distribution

    Nationwide Distribution including NY, OH, PA, and TX.

    Quantity

    seven units