BEUDAMED
    FDA Recall Terminated

    Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Howmedica Osteonics Corp. 325 Corporate Drive; Mahwah, NJ 07430; A subsidiary of Stryker Corp. Sterile, Made in USA.

    Recall: Z-0072-2008 · Initiated August 30, 2007

    Recall

    Recall Number
    Z-0072-2008
    Event Number
    44780
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 30, 2007
    Posted
    October 25, 2007
    Terminated
    September 5, 2008
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Trident PSL HA Cluster Acetabular Shell; Arc Deposited HA Coated Cluster Screw Holes. Hip prosthesis component. Howmedica Osteonics Corp. 325 Corporate Drive; Mahwah, NJ 07430; A subsidiary of Stryker Corp. Sterile, Made in USA.

    Reason

    Stryker Orthopaedics had identified that specific lots of Trident PSL Acetabular shells may have a dimensional discrepancy. The deviation regarding the difference in wall thickness will increase the gap between the shell and liner on one side and will decrease the gap between shell and liner on the opposing side, resulting in interference.

    Action

    Recall notification letters were sent out on August 30, 2007 with return receipt.

    Distribution

    Product was distributed nationwide and one unit to Brazil.

    Quantity

    142 units