BEUDAMED
    FDA Recall Terminated

    Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989

    Recall: Z-1081-2019 · Initiated February 28, 2019

    Recall

    Recall Number
    Z-1081-2019
    Event Number
    82324
    Firm
    Zimmer Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KIH
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    February 28, 2019
    Terminated
    April 23, 2020
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Biomet Small Diameter Cement Plug Inserter-Sterile, single-use accessory instrumentation to be used during surgical procedures utilizing the Small Diameter Cement Plug implant devices Item Number: 414989

    Reason

    Lack of an adequate sterilization validation

    Action

    Zimmer Biomet issued recall letter on 2/28/19 via FedEx and email identifying reason for recall to the consumer/user level, including any intermediate wholesale or retail consignees. Distributors responsibilities include locating and removing the product in their territory, as well as identifying hospitals and surgeons who have previously used the product. " Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. " Surgeons provided with a letter that identifies the issue and their responsibilities, which include: - Following any specified patient monitoring instructions - Returning Certificate of Acknowledgment to Zimmer Biomet. " Hospital risk managers provided with a letter identifying the issue and their responsibilities. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday

    Distribution

    Nationwide

    Quantity

    89 units