BEUDAMED
    FDA Recall Terminated

    Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

    Recall: Z-0027-06 · Initiated August 23, 2005

    Recall

    Recall Number
    Z-0027-06
    Event Number
    33279
    Firm
    Zimmer Inc.
    FEI Number
    1000220733
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 23, 2005
    Posted
    October 7, 2005
    Terminated
    December 8, 2005
    Address
    345 E Main St, Warsaw, IN, 46580-2746

    Description

    Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 52 mm dia. articular surface, med, sterile, for cemented use only in the USA, Cat. no. 00430604652.

    Reason

    The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement.

    Action

    Consignees were notified via letter dated August 23, 2005 or by email.

    Distribution

    Nationwide, Australia, Canada, England, Germany and Italy.