BEUDAMED
    FDA Recall Terminated

    Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)

    Recall: Z-0939-2018 · Initiated January 3, 2018

    Recall

    Recall Number
    Z-0939-2018
    Event Number
    79397
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    LPH
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    January 3, 2018
    Terminated
    April 11, 2019
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Trabecular Metal Primary Hip Prosthesis; Part Numbers: 1. 00-7864-013-00 (UDI: (01) 00889024139251 (17) 250731 (10) 63703649), and 2. 00-7864-013-20 (UDI: (01) 00889024139268 (17) 250731 (10) 63703681)

    Reason

    Two lots of hip implants are mislabeled.

    Action

    DISTRIBUTORS: 1. Review this notification and notify affected team members of the contents. 2. Immediately locate and quarantine affected product. 3. Immediately return all affected product from your distributorship and from affected hospitals within your territory. a. Complete Inventory Return Certification Form and send to [email protected] within three (3) days. Mark RECALL on the outside of the returned cartons. 4. Return the Additional Accounts form to [email protected] RISK MANAGERS: 1. Review this notification and notify affected personnel of the contents. 2. Quarantine all affected product. Your sales representative will remove the affected product from your facility. 3. Complete Certificate of Acknowledgement and send to [email protected].

    Distribution

    Distributed in 2 US states: LA and NY. Distributed in Canada, China, Japan, and Switzerland.

    Quantity

    24