BEUDAMED
    FDA Recall Terminated

    Trident Insert Impactor

    Recall: Z-0901-03 · Initiated April 28, 2003

    Recall

    Recall Number
    Z-0901-03
    Event Number
    26267
    Firm
    Stryker Howmedica Osteonics
    FEI Number
    3003070421
    Product Code
    HWA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    April 28, 2003
    Posted
    May 29, 2003
    Terminated
    November 12, 2003
    Address
    300 Commerce Court, Mahwah, NJ, 07430

    Description

    Trident Insert Impactor

    Reason

    The ball retaining sleeve on the Trident Insert Impactor can possibly disassemble.

    Action

    Howmedica sent recall letters and acknowledgement forms via FedEx on April 29, 2003 with return receipt.

    Distribution

    The product has been distributed the Howmedica branches and sales reps, hospitals, and International Howmedica distributors located in Sweden, China, France, Netherlands, Germany, Spain, Australia, Japan, New Zealand, Switzerland, Portugal, England, Chile, and Brazil.

    Quantity

    1758