BEUDAMED
    FDA Enforcement Class II Ongoing

    Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

    Recall: Z-3309-2024 · Reported October 9, 2024

    Enforcement

    Recall Number
    Z-3309-2024
    Event ID
    95245
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tornier, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 9, 2024
    Initiation Date
    August 29, 2024
    Classification Date
    September 27, 2024
    Address
    10801 Nesbitt Ave S, N/A, Bloomington, MN, 55437-3109, United States

    Description

    Stryker Tornier Perform Humeral System, Reversed Insert, 45%, REF DWP2393, for shoulder arthroplasty

    Reason

    Devices from one lot of Perform" Reversed Inserts may contain a locking ring that was assembled upside down which would prevent the humeral insert from securely seating in the stem or spacer.

    Code Info

    GTIN 00846832084494, Batch Lot # 1495AY

    Distribution

    US Nationwide distribution.

    Quantity

    38 units