BEUDAMED
    FDA Recall Terminated

    Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument

    Recall: Z-0914-2022 · Initiated February 10, 2022

    Recall

    Recall Number
    Z-0914-2022
    Event Number
    89764
    Firm
    Nextremity Solutions
    FEI Number
    3009540749
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 10, 2022
    Terminated
    October 10, 2024
    Address
    1195 Polk Dr, Warsaw, IN, 46582-8602

    Description

    Nextra Hammertoe Correction System Driver SKU: NX-DR Orthopedic surgical instrument

    Reason

    Proximal end of the driver is oversized in varying degrees, making it difficult to fully connect with and remove from the proximal Nextra implant, causing delay in surgery

    Action

    Nextremity Solutions issued Urgent Medical Device Recall letter on 2/10/22 via mail and email to Distributors and Risk Mangers. Nextremity Solutions products with the referenced part and lot number should not be used and should be quarantined and returned to Zimmer Biomet for return to Nextremity Solutions. If you have affected product at your facility, locate and quarantine affected product in your inventory. Zimmer Biomet Sales representative will remove the affected product from your facility. Complete Medical Device Recall Return Response and send to [email protected], even if you do not have affected products at your facility. 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. Or email to [email protected].

    Distribution

    Distribution US Nationwide, Japan, and the Netherlands

    Quantity

    239 units