BEUDAMED
    FDA Recall Open, Classified

    Identity Shoulder System Resection Planer 35mm Resection Planer

    Recall: Z-1098-2023 · Initiated December 7, 2022

    Recall

    Recall Number
    Z-1098-2023
    Event Number
    91468
    Firm
    Zimmer, Inc.
    FEI Number
    1000220733
    Product Code
    HTO
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 7, 2022
    Posted
    February 6, 2023
    Address
    1800 W Center St, Warsaw, IN, 46580-2304

    Description

    Identity Shoulder System Resection Planer 35mm Resection Planer

    Reason

    Two planers were found to be unusable during sawbones shoulder training.

    Action

    Consignee notification was made to impacted distributors and hospitals beginning December 27, 2022. Consignees are asked to immediately check inventory and quarantine any impacted devices. Return of product is to be made to Zimmer Biomet via an Inventory Return Certification Form. This form shall be completed even if there is no impacted inventory.

    Distribution

    US Nationwide distribution in the states of AR, CA, IL, MI, NJ, NY, OK, PA, TX, and WA.

    Quantity

    84 units