BEUDAMED
    FDA Recall Terminated

    Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)

    Recall: Z-1239-2018 · Initiated January 24, 2018

    Recall

    Recall Number
    Z-1239-2018
    Event Number
    79400
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1000220733
    Product Code
    JDC
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    January 24, 2018
    Posted
    March 14, 2018
    Terminated
    April 9, 2019
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Coonrad/Morrey Elbow Implant System humeral assembly 4IN XSML, Item Number: 32-8105-027-04 (UDI: (01)0088902427 4006(17)220731(10)63694912)

    Reason

    One lot of humeral stem implants do not include the humeral bushing components.

    Action

    1. Immediately locate and quarantine affected product in your inventory. 2. 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. b. Request a Return Authorization Number. Mark RECALL on the outside of the returned cartons.

    Distribution

    Distributed in China and Taiwan.

    Quantity

    9