BEUDAMED
    FDA Recall Terminated

    THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.

    Recall: Z-1347-2020 · Initiated January 7, 2020

    Recall

    Recall Number
    Z-1347-2020
    Event Number
    84753
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    JDO
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 7, 2020
    Posted
    January 29, 2020
    Terminated
    April 8, 2021
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.

    Reason

    Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.

    Action

    On January 7, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to take the following actions: 1. Review the recall information and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. The sales representative will remove the affected product from your facility. 3. There are no specific patient monitoring instructions related to this recall that are recommended beyond the existing follow-up schedule. IF there is a device fracture, it can be detected through x-rays. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to [email protected].

    Distribution

    Domestic distribution to AL CA FL IA IL MD MI MN MO MS NC NE NJ NY PA TX UT VA WA WI

    Quantity

    1662