BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1403-2025 · Reported March 26, 2025

    Enforcement

    Recall Number
    Z-1403-2025
    Event ID
    96398
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    ZIMMER ORTHOPEDICS MANFACTURING LIMITED-GALWAY
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 26, 2025
    Initiation Date
    March 3, 2025
    Classification Date
    March 20, 2025
    Address
    Deerpark Industrial Estate, N/A, Oranmore, N/A, N/A, Ireland

    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.

    Code Info

    Item No. 113605, UDI-DI 00887868267550 Lots 66173214, 66173215; Item No. 113606, UDI-DI 00887868267567 Lots 66173216, 66173218, 66173219; Item No. 113607, UDI-DI 00887868267574 Lots 66173220, 66173221; Item No. 113627, UDI-DI 00887868267741 Lots 65901697, 65909480, 65915809

    Distribution

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

    Quantity

    90 US; 136 OUS