BEUDAMED
    FDA Enforcement Class II Terminated

    Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

    Recall: Z-0734-2019 · Reported January 23, 2019

    Enforcement

    Recall Number
    Z-0734-2019
    Event ID
    81758
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Zimmer Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 23, 2019
    Initiation Date
    November 28, 2018
    Classification Date
    January 14, 2019
    Termination Date
    May 12, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989, United States

    Description

    Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

    Reason

    There is a potential for silicone shedding during cleaning and sterilization.

    Code Info

    Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512868

    Distribution

    Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.

    Quantity

    971 i nTotal