BEUDAMED
    FDA Recall Terminated

    Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430

    Recall: Z-1170-2008 · Initiated January 21, 2008

    Recall

    Recall Number
    Z-1170-2008
    Event Number
    46691
    Firm
    Stryker Howmedica Osteonics Corp.
    FEI Number
    3003070421
    Product Code
    MEH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    January 21, 2008
    Posted
    June 12, 2008
    Terminated
    September 25, 2012
    Address
    325 Corporate Dr, Mahwah, NJ, 07430-2002

    Description

    Trident Hemispherical Cluster; 42mm - 74 mm Arc Deposited; Hydroxylapatite Coated; Multiholed; Use with Size A insert; hip prosthesis component, Stryker Orthopaedics, Howmedica Osteonics Corp, Mahwah, NJ 07430

    Reason

    Foreign material: Some of the parts tested exceeded Stryker Orthopaedics internal acceptance criteria for manufacturing residuals.

    Action

    Recall notification letters were sent to Stryker Branches/agencies, OR Supervisors and Chief of Orthopaedics on 1/21/08. A Patient information sheet was sent on 2/4/08 to surgeons and hospitals. Per call with Center 2/4/08, recall letter to be revised and RES updated upon receipt. The letter was revised and sent on February 28, 2008 to include Trident PSL Acetabular shells. This letter was sent to Risk Management at hospitals and included the scope of the recall , the potential hazard and recommendation to physicians to monitor patients consistent with care for those receiving total hip replacement. It was also sent to surgeons and a revised letter to Stryker branches. A product acknowledgement form was included in all letters to indicate receipt of letter and quantity of product on hand, if applicable.

    Distribution

    Nationwide distribution.

    Quantity

    129,312 total shells, all Trident Hemispherical types