BEUDAMED
    FDA Recall Terminated

    V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

    Recall: Z-1822-2009 · Initiated June 18, 2009

    Recall

    Recall Number
    Z-1822-2009
    Event Number
    52525
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    LWJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    June 18, 2009
    Posted
    August 18, 2009
    Terminated
    August 27, 2012
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    V 40 Femoral Head, Sterile, 22 mm; Catalog number 6260-4-122, Catalog number 6260-5-226; Howmedica Osteonics Corp., Stryker Ireland, Carrigtwohill County Cork, Ireland; Intended for use with femoral stems and acetabular components in primary or revision total hip arthroplasty.

    Reason

    Sterilization issue: During post-sterilization inspection of the outer blister packaging of the affected lots, it was determined that the outer blister did not meet the required minimum seal width.

    Action

    Urgent Product Recall letters were sent via Federal Express on June 18, 2009 to all Stryker Branches/Agencies, hospital Risk Management, hospital Chief of Orthopaedics and surgeons who may have used the recalled products. The letters stated the issue, potential hazards, and the risk mitigation. Customers may contact Colleen O'Meara at 201-831-5970 with any questions.

    Distribution

    Nationwide Distribution

    Quantity

    13 total, both products.