BEUDAMED
    FDA Enforcement Class II Terminated

    Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.

    Recall: Z-0696-2021 · Reported December 30, 2020

    Enforcement

    Recall Number
    Z-0696-2021
    Event ID
    86869
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 30, 2020
    Initiation Date
    November 20, 2020
    Classification Date
    December 22, 2020
    Termination Date
    May 26, 2022
    Address
    1800 W Center St, N/A, Warsaw, IN, 46580-2304, United States

    Description

    Spinal Rod Cutter, Item number 00392500200. The product is a nonsterile pin cutter - Product Usage: The intended use of this instrument is to be used for cutting orthopedic rods/pins during orthopedic surgeries.

    Reason

    Device has the potential for fracture during use.

    Code Info

    All lots

    Distribution

    Domestic distribution nationwide. Foreign distribution to Australia, China, Hong Kong, India, Japan, Korea, New Zealand, Taiwan, Singapore, Thailand, Canada, Netherlands, Argentina, Brazil, Mexico, Venezuela, Panama, and Chile.

    Quantity

    4713