BEUDAMED
    FDA Recall Terminated

    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

    Recall: Z-1657-2020 · Initiated February 26, 2020

    Recall

    Recall Number
    Z-1657-2020
    Event Number
    85153
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 26, 2020
    Posted
    April 3, 2020
    Terminated
    July 29, 2021
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    BIOMET StageOne, Shoulder Cement Spacer Mold 6 MM, 42 X 18 X 46 MM, Silicone, Sterile, Item 431406.

    Reason

    Potentially insufficient cleaning process or potential inadequate process monitoring for cleaning parameters.

    Action

    On 2/26/2020, Zimmer Biomet sent an "Urgent Medical Device Recall" letter via FEDEX to direct sales distributors, hospitals, and surgeons. In addition, an email was sent to all distributors alerting them of the recall. Customers were instructed to quarantine the product and a Zimmer Biomet representative would remove the affected product from the facility. They asked customers to complete and return the "Certificate of Acknowledgement" form indicating whether they had any of the affected lots.

    Distribution

    Worldwide distribution. US distribution to the following states: Alaska, Alabama, Arkansas, Arizona, California, Colorado, Connecticut, Delaware, Florida, Georgia, Hawaii, Iowa, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Maine, Michigan, Minnesota, Missouri, Mississippi, Montana, North Carolina, North Dakota, Nebraska, New Hampshire, New Jersey, New Mexico, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, West Virginia, Wyoming, and the District of Columbia.

    Quantity

    230,001