BEUDAMED
    FDA Enforcement Class II 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 · Reported March 21, 2018

    Enforcement

    Recall Number
    Z-0939-2018
    Event ID
    79397
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 21, 2018
    Initiation Date
    January 3, 2018
    Classification Date
    March 9, 2018
    Termination Date
    April 11, 2019
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    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.

    Code Info

    Part Numbers: 1. 00-7864-013-00, Lot: 63703649; 2. 00-7864-013-20, Lot: 63703681

    Distribution

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

    Quantity

    24