BEUDAMED
    FDA Recall Terminated

    BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813 47430103100

    Recall: Z-0298-2020 · Initiated October 10, 2019

    Recall

    Recall Number
    Z-0298-2020
    Event Number
    83962
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    KWT
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    October 10, 2019
    Terminated
    May 19, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    BF Humeral Stem, Various Sizes, Item Nos. 00430000606 00430000613 00430000706 00430000713 00430000813 00430000817 00430000820 00430000913 00430001013 00430001017 00430001020 00430001113 00430001213 00430001217 00430001220 00430001313 00430001413 00430001417 00430001420 00430001513 00430001613 00430001713 00430001813 47430103100

    Reason

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

    Action

    The firm distributed Urgent Medical Device Correction letters to customers on October 10, 2019. The letter informed customers that the previous version of low density polyethylene (LDPE) bag could potentially adhere to the surface of metal devices. Please note, this is separate from the previous recall for highly polished implants packaged in the previous version of the LDPE bags. Customers were asked to take the following actions: 1. Review this notification and ensure that pertinent personnel are aware of the contents. 2. Ensure that backup devices for the affected products are available, as per standard orthopedic procedure planning, to reduce the likelihood of an extension of surgery time. 3. Examine devices thoroughly for adherent LDPE bag residue prior to use. Use a backup device if LDPE bag residue is detected. 4. Return any devices which display adherent LDPE bag residue to Zimmer Biomet, consistent with the standard instructions for use regarding the disposition of damaged components. 5. Complete the Certificate of Acknowledgement and return to the firm. 6. Retain a copy of the acknowledgement form with your field action records in the event of a compliance audit of your facility's documentation. If you have further questions or concerns regarding this recall, please call the firm's 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

    Distributed nationwide.

    Quantity

    5,459,583 total devices