BEUDAMED
    FDA Enforcement Class II Terminated

    Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235

    Recall: Z-2362-2020 · Reported June 24, 2020

    Enforcement

    Recall Number
    Z-2362-2020
    Event ID
    85641
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 24, 2020
    Initiation Date
    May 1, 2020
    Classification Date
    June 12, 2020
    Termination Date
    July 28, 2021
    Address
    6303 Blue Lagoon Dr Ste 100, Miami, FL, 33126-6023, United States

    Description

    Biomet Outer Sheath 4.5/5.0,6.5- Orthopedic Manual Surgical Instrument Product Code: 14235

    Reason

    Device and tray that houses the device did not pass steam sterilization process validation testing

    Code Info

    All lots

    Distribution

    Nationwide Foreign: CHINA, AUSTRALIA, CHILE, COSTA RICA , NETHERLANDS, SWITZERLAND

    Quantity

    136 units