BEUDAMED
    FDA Recall Terminated

    Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.

    Recall: Z-1703-2009 · Initiated June 9, 2009

    Recall

    Recall Number
    Z-1703-2009
    Event Number
    52289
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MRA
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    June 9, 2009
    Posted
    August 4, 2009
    Terminated
    May 8, 2012
    Address
    325 Corporate Dr, Mahwah, NJ, 07430

    Description

    Trident Acetabular System Surgical Protocol. Instructions for use of hip prosthesis. Literature Number LSP55.

    Reason

    The Surgical Protocol has been modified to create separate and distinct surgical protocols, one for the Trident PSL Shell (LSP68) and one for the Trident Hemispherical Shell (LSP69) in order to clarify and highlight the differences in reaming technique.

    Action

    Stryker sent Urgent - Product Correction - Surgical Protocol letters by Federal Express on June 9, 2009 to all Stryker branches/agencies, hospital Risk Management, hospital Chief of Orthopaedics, surgeons and all foreign consignees.

    Distribution

    Worldwide distribution.

    Quantity

    2376 in USA, 1326 internationally