BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Oxford Partial Knee Phase 3 / Domed Lateral Femoral Drill Guide: Item Number: 32-421930 System Domed Lateral Femoral Drill Guide Small

    Recall: Z-1741-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1741-2019
    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: 32-421930 System Domed Lateral Femoral Drill Guide Small

    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: ZB160101 ZB160801 ZB160801

    Distribution

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

    Quantity

    15