BEUDAMED
    FDA Recall Terminated

    Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

    Recall: Z-0775-2020 · Initiated November 4, 2019

    Recall

    Recall Number
    Z-0775-2020
    Event Number
    84397
    Firm
    Medacta Usa Inc
    FEI Number
    3006639916
    Product Code
    KWS
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    November 4, 2019
    Terminated
    May 21, 2021
    Address
    3973 Delp St, Memphis, TN, 38118-6110

    Description

    Medacta Shoulder SYSTEM HUMERAL ANATOMICAL METAPHYSIS, REF 04.01.0023 through 04.01.0055, all sizes - Product Usage: The Medacta Anatomic Shoulder Prosthesis is indicated for treatment of humeral fractures and for primary or revision total shoulder replacement in patients with an intact or reparable rotator cuff shoulder joint, severe arthropathy or a previously failed joint replacement.

    Reason

    Certain lot numbers of the Medacta Humeral Anatomical Cementless Metaphysis have a dimensional condition that could limit insertion of the screw used to lock the metaphysis to the humeral diaphysis.

    Action

    On 11/4/19 all distributors with recalled product were immediately notified of the recall by phone. On 11/5/19, all distributors were further notified of the recall via email and requested to return their product to the Memphis warehouse.

    Distribution

    US Nationwide distribution in the states of KY, NJ, IL, SC, CA, TX, ID, AR, OH.

    Quantity

    207 units