BEUDAMED
    FDA Enforcement Class II Terminated

    BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.

    Recall: Z-0809-2022 · Reported March 30, 2022

    Enforcement

    Recall Number
    Z-0809-2022
    Event ID
    89701
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 30, 2022
    Initiation Date
    February 14, 2022
    Classification Date
    March 18, 2022
    Termination Date
    September 30, 2024
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    BIOMET Sports Medicine JUGGERLOC SLOTTED REAMER: [Item # 110010371, 6MM], [Item #110010372, 7MM], [Item # 110010373, 8MM], [Item #110018275, 5MM]. Devices are packaged in a vacuum sealed nylon pouch, which is placed in a carton with the appropriate IFU and patient record labels. Identifying labels on the pouch and the carton.

    Reason

    Packaging of various implants may not have sufficient adhesion on all sides, leading to loss of sterile barrier integrity. Use of product poses risk of infection, leading to surgical intervention, and/or extension of surgery to find another part.

    Code Info

    29 lots: Lot Number, UDI Number - [061400, (01)00887868465758(17)310630(10)061400], [061410, (01)00887868465758(17)310723(10)061410], [089370, (01)00887868465758(17)310726(10)089370], [260770, (01)00880304857261(17)310917(10)260770], [503410, (01)00880304857285(17)311011(10)503410], [503420, (01)00880304857261(17)310924(10)503420], [503430, (01)00880304857285(17)311011(10)503430], [503450, (01)00880304857261(17)310924(10)503450], [503460, (01)00880304857285(17)311011(10)503460], [503610, (01)00880304857285(17)310924(10)503610], [539370, (01)00880304857285(17)311105(10)539370], [549910, (01)00887868465758(17)310603(10)549910], [577830, (01)00880304857292(17)310917(10)577830], [577840, (01)00880304857292(17)310922(10)577840], [577860, (01)00880304857292(17)310917(10)577860], [637200, (01)00880304857285(17)311027(10)637200], [796600, (01)00880304857285(17)311105(10)796600], [796610, (01)00880304857261(17)311027(10)796610], [886120, (01)00880304857285(17)310805(10)886120], [886200, (01)00880304857285(17)310805(10)886200], [886210, (01)00880304857285(17)310727(10)886210], [886220, (01)00880304857285(17)310726(10)886220], [886230, (01)00880304857285(17)310813(10)886230], [886240, (01)00880304857285(17)310805(10)886240], [886260, (01)00880304857285(17)310922(10)886260], [886270, (01)00880304857285(17)310922(10)886270], [886290, (01)00880304857285(17)310917(10)886290], [954740, (01)00880304857285(17)310922(10)954740], [954760, (01)00880304857285(17)310922(10)954760]

    Distribution

    Worldwide: US (28 States AL, AZ, CA, CO, CT, FL, GA, ID, IL, IN, KS, KY, LA, MD, MI, MS, NC, NE, NM, NY, OH, OK, OR, SC, TX, UT, WA, WY), Australia, Japan, and Netherlands

    Quantity

    702