BEUDAMED
    FDA Recall Terminated

    Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

    Recall: Z-0735-2019 · Initiated November 28, 2018

    Recall

    Recall Number
    Z-0735-2019
    Event Number
    81758
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    FSM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 28, 2018
    Terminated
    May 12, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Maximum Variable Pitch Compression Screw Caddy, Reference Number 231201003 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.

    Action

    Urgent Medical Device Correction notification letters dated 11/28/18 were distributed to customers. The letter identified the affected product, problem and actions to be taken.

    Distribution

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

    Quantity

    971 in total