BEUDAMED
    FDA Recall Open, Classified

    Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627

    Recall: Z-1403-2025 · Initiated March 3, 2025

    Recall

    Recall Number
    Z-1403-2025
    Event Number
    96398
    Firm
    ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY Deerpark Industrial Estate Oranmore Ireland
    FEI Number
    3012319330
    Product Code
    MBF
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 3, 2025
    Posted
    March 20, 2025

    Description

    Comprehensive Shoulder Stem, Comprehensive Micro Stem, Comprehensive Mini Stem; uncemented shoulder prosthesis, Model Nos. 113605, 113606, 113607, 113627

    Reason

    Five complaints received where surgeon was unable to remove and/or connect the inserter with the stem during surgery due to excess material remaining within the taper. Issue may lead to clinically significant extension of surgery to find a replacement.

    Action

    On March 3, 2025, the firm notified affected customers via Urgent Medical Device Recall letters. Customers were informed of the excess metal on the inner taper of the stem due to a chipped manufacturing tool. Customers were asked to notify all affected persons and assist their Zimmer Biomet sales representative in quarantining all affected product on hand. The products will be removed from your facility.

    Distribution

    US distribution nationwide. International distribution to Dominican Republic, Canada, India, Australia, Japan, EMEA, Korea, Taiwan, and Hong Kong.

    Quantity

    90 US; 136 OUS