BEUDAMED
    FDA Recall Terminated

    Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are 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. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

    Recall: Z-2541-2011 · Initiated April 22, 2011

    Recall

    Recall Number
    Z-2541-2011
    Event Number
    58571
    Firm
    Biomet, Inc.
    FEI Number
    1825034
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    April 22, 2011
    Posted
    June 9, 2011
    Terminated
    February 21, 2013
    Address
    56 E Bell Dr, Warsaw, IN, 46582

    Description

    Bio-modular reverse shoulder humeral tray with lock ring, 44 mm 10 degree angle, sterile, single use, REF 11-113685, Biomet Orthopedics, Warsaw, IN. Biomet Comprehensive Reverse Shoulder products are 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. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.

    Reason

    The firm is initiating this recall following an investigation which identified the rare possibility that certain units of Comprehensive Reverse Shoulder Humeral Trays may contain a locking ring that is incorrectly assembled.

    Action

    The firm, Biomet Orthopedics, sent an "URGENT MEDICAL DEVICE RECALL" letter dated April 22, 2011 to their customers. The letter describes the product, problem, and actions to be taken. The customers were instructed to immediately locate the recalled product; discontinue use; return the product back to Biomet; confirm receipt of the notice by calling 800-348-9500 extension 1368 or 1325, and complete and return the attached form via fax to: 574-372-1683 or mail to: Biomet, 56 East Bell Drive, Warsaw, IN 46580. Customers with questions regarding this recall should call 800-348-9500 extension 1368 or 1325.

    Distribution

    Worldwide distribution: USA (nationwide) including: Puerto Rico and countries including: Australia, Canada, Chile, Columbia, Costa Rica, Korea and Netherlands.

    Quantity

    1,575 units all products