BEUDAMED
    FDA Recall Terminated

    PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800404 00234800408 00234800412

    Recall: Z-0313-2020 · Initiated October 10, 2019

    Recall

    Recall Number
    Z-0313-2020
    Event Number
    83962
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    HRS
    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

    PERIARTICULAR PLATES SHOULDER, PERI PROX LAT HUMERAL, Item Nos. 00234800104 00234800106 00234800108 00234800110 00234800112 00234800114 00234800116 00234800204 00234800206 00234800208 00234800210 00234800212 00234800214 00234800216 00234800304 00234800306 00234800404 00234800408 00234800412

    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