BEUDAMED
    FDA Recall Terminated

    M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093

    Recall: Z-1046-2016 · Initiated February 11, 2016

    Recall

    Recall Number
    Z-1046-2016
    Event Number
    73298
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 11, 2016
    Terminated
    December 1, 2016
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093

    Reason

    Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.

    Action

    Zimmer, Inc. initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. Electronic notices were e-mailed to distributors, and letters were mailed via certified mail on 02/11/2016 to distributors and hospitals. A field complaint investigation confirmed that this single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended Offset, and the device is an extended offset stem. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers and surgeons will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: Assisting the Zimmer Biomet sales representative with the quarantine of the product and completion and return of the Acknowledgement Form. Customers are asked to complete the Certificate of Acknowledgement Form and return to [email protected]. Customers with have further questions or concerns please call the customer call center at 1-800-348-2759 between 8:00 am and 8:00 pm EST.

    Distribution

    Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.

    Quantity

    9 units