BEUDAMED
    FDA Recall Terminated

    Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories

    Recall: Z-1816-2016 · Initiated April 1, 2016

    Recall

    Recall Number
    Z-1816-2016
    Event Number
    74038
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    GEA
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    April 1, 2016
    Posted
    May 26, 2016
    Terminated
    May 23, 2017
    Address
    56 E Bell Dr, Warsaw, IN, 46582-6989

    Description

    Various trauma and sports medicine instruments and implants. cannula, surgical, general & plastic surgery and accessories

    Reason

    Insufficient seal strength on sterile barrier packaging. The seal could be jeopardized causing the sterile barrier to be compromised and the product could become nonsterile. If the product becomes non-sterile and is used or implanted, it may lead to an infection.

    Action

    Zimmer Biomet sent an Urgent Medical Device Recall Notice dated April 1, 2016, to all affected customers. Customers were instructed to locate and return the affected product, and implanting surgeons were instructed to monitor patients. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Questions related to this notice should be directed to (574) 372-1570, Monday through Friday, 8 a.m. to 5 p.m.

    Distribution

    Worldwide Distribution - US (Nationwide) and globally to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Ecaudor, The Netherlands, Japan, Korea, Malaysia, Mexico, Peru.