BEUDAMED
    FDA Recall Terminated

    Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.

    Recall: Z-0467-03 · Initiated December 2, 2002

    Recall

    Recall Number
    Z-0467-03
    Event Number
    25321
    Firm
    Stryker Howmedica Osteonics
    FEI Number
    3003070421
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 2, 2002
    Posted
    January 28, 2003
    Terminated
    August 1, 2003
    Address
    300 Commerce Court, Mahwah, NJ, 07430

    Description

    Restoration #8 HA Hip Stem, Catalog No. 6013-1216 and Restoration #8 HA Hip Stem, Catalog No. 6013-1218.

    Reason

    Product mix-up. 16mm stem in a 18mm package.

    Action

    Branches and agents were notified via letter on 12/2/2002. Hospitals were notified on 12/2/2002 via FedEx to OR Supervisors.

    Distribution

    The product was shipped to 2 Howmedica branches, 1 hospital, one government hospital, and 2 international distributors. Government hospital is the VA Medical Center, Tampa, FL.. Two international customers are Stryker Howmedica affiliates in Chile and Spain.

    Quantity

    6