BEUDAMED
    FDA Enforcement Class II Terminated

    Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.

    Recall: Z-2025-2021 · Reported July 21, 2021

    Enforcement

    Recall Number
    Z-2025-2021
    Event ID
    88004
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Tornier, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 21, 2021
    Initiation Date
    May 28, 2021
    Classification Date
    July 12, 2021
    Termination Date
    April 14, 2023
    Address
    10801 Nesbitt Ave S, Bloomington, MN, 55437-3109, United States

    Description

    Aequalis Ascend Flex Shoulder System Reversed Platform (Reversed Tray component) Rx Only Sterile Manufacturer Tornier SAS - Saint Martin, France. Shoulder prosthesis component.

    Reason

    Two lots have been swapped thus have the incorrect product in the package. The component may be of a different thickness.

    Code Info

    Item Number DWF500 Lot # 1179AW Exp. Date 2026-02-24 and Item Number DWF510 Lot # 1197AW Exp. Date 2026-02-25

    Distribution

    IL and TX Belgium, France and United Kingdom

    Quantity

    20