BEUDAMED
    FDA Enforcement Class II Terminated

    Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

    Recall: Z-2144-2020 · Reported June 3, 2020

    Enforcement

    Recall Number
    Z-2144-2020
    Event ID
    85524
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Biomet, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 3, 2020
    Initiation Date
    April 17, 2020
    Classification Date
    May 28, 2020
    Termination Date
    June 25, 2021
    Address
    56 E Bell Dr, N/A, Warsaw, IN, 46582-6989, United States

    Description

    Extremities Item Number: 1)113954 Hybrid Glenoid Glenoid Base, 4 MM 2) XL-115366 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 41 MM, Standard 3) XL-115364 Comprehensive Reverse Shoulder Humeral Bearing, ArComXL, 44 MM X 36 MM, +3MM Standard Product Usage: is indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff.

    Reason

    Potential presence of elevated endotoxin levels that exceed the specification limit

    Code Info

    Lot Numbers: 1)597000 UDI (01)00880304462489(17)211229(10)597000 2) 502510 UDI (01)00880304475458(17)211229(10)502510 3) 744880 UDI (01)00880304475434(17)220117(10)744880

    Distribution

    Worldwide distribution - US Nationwide distribution and the countries of Canada, AHMADABAD, GUJARAT, BANGKOK, BELROSE NSW, BUENOS AIRES, CHILE, COSTA RICA, HIRATSUKA CITY, HUECHURABA SANTIAGO, INDIA, JAPAN, MEXICO DF, NETHERLANDS, PICHINCHA, EC, SAN JOSE, SINGAPORE, TAIWAN, THAILAND, YONGSAN-GU SEOUL.

    Quantity

    122 units