BEUDAMED
    FDA Recall Terminated

    Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35 (00662406535).

    Recall: Z-1346-06 · Initiated June 26, 2006

    Recall

    Recall Number
    Z-1346-06
    Event Number
    35784
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 26, 2006
    Posted
    August 3, 2006
    Terminated
    December 5, 2007
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer HGP II Acetabular Components Bone Screw, self-tapping, 6.5 mm dia., 35 mm length, tivanium TI-6AL-4V alloy, sterile, Catalog no. 6624-65-35 (00662406535).

    Reason

    Lack of assurance of sterility, as the sterile barrier packaging may have been compromised.

    Action

    Hospital accounts were notified via recall letter dated 6/26/06 and distributor accounts were notified via recall letter dated 6/28/06 to return the product. Recall was extended to additional lots via recall letter dated 7/26/06.

    Distribution

    Worldwide, including USA, Argentina, Brazil, Canada, China, England, France, Germany, Guatemala, Israel, Japan, Jordan, Lebanon, Poland, Saudi Arabia, Singapore, Spain, Taiwan, UAE.

    Quantity

    310 total for all catalog numbers