BEUDAMED
    FDA Recall Terminated

    Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts.

    Recall: Z-1685-2009 · Initiated May 29, 2007

    Recall

    Recall Number
    Z-1685-2009
    Event Number
    50097
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    May 29, 2007
    Posted
    August 13, 2009
    Terminated
    August 17, 2009
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    Trident Hemispherical Acetabular Shell; 72mm, Arc Deposited, Hydroxylapatite Coated, Multi holed; Sterile; Stryker, France. Single use devices intended for cementless fixation within the prepared acetabulum. Intended for use with the mating Trident Polyethylen Cup Inserts.

    Reason

    Stryker Orthopaedics became aware that Trident Hemispherical Shells, Catalog Number 508-11-74J, are actually marked and labeled as Catalog Number 598-11-72J, Lot Code 20282301

    Action

    Stryker Orthopaedics issued an "Important Market Withdrawal" notice via Federal Express dated May 29, 2007. Consignees were asked to locate and return affected product and fax the attached Product Accountability Form to 1-201-831-6069. For further questions, contact Stryker Orthopaedics at 1-201-831-5825.

    Distribution

    Distributed to 2 Stryker branches.

    Quantity

    2 units