BEUDAMED
    FDA Enforcement Class II Terminated

    Various trauma and sports medicine instruments and implants. Bit, drill.

    Recall: Z-1821-2016 · Reported June 1, 2016

    Enforcement

    Recall Number
    Z-1821-2016
    Event ID
    74038
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 1, 2016
    Initiation Date
    April 1, 2016
    Classification Date
    May 26, 2016
    Termination Date
    May 23, 2017
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Various trauma and sports medicine instruments and implants. Bit, drill.

    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.

    Code Info

    Part #'s 24445 27961 904301 904760 231201307 Lot #'s 693880 606180 614250 668360 625470 710630 710640 668330

    Distribution

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

    Quantity

    N/A