BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium

    Recall: Z-1737-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1737-2019
    Event ID
    82818
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 12, 2019
    Initiation Date
    April 18, 2019
    Classification Date
    June 6, 2019
    Termination Date
    September 10, 2020
    Address
    1800 W Center St, Warsaw, IN, 46580-2304, United States

    Description

    Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-420322 Phase 3 Femoral Drill Guide Medium

    Reason

    Incorrect raw material used by the supplier in the manufacturing of the screw component, which could potentially lead to corrosion.

    Code Info

    Lot Numbers: ZB130801

    Distribution

    CA, IN, LA, NM, NY, TX, WI Foreign: CANADA, AUSTRALIA, JAPAN, NETHERLANDS

    Quantity

    10 units