BEUDAMED
    FDA Enforcement Class II Ongoing

    stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

    Recall: Z-0113-2024 · Reported October 25, 2023

    Enforcement

    Recall Number
    Z-0113-2024
    Event ID
    93051
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Tornier, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    October 25, 2023
    Initiation Date
    September 15, 2023
    Classification Date
    October 13, 2023
    Address
    10801 Nesbitt Ave S, N/A, Bloomington, MN, 55437-3109, United States

    Description

    stryker Tornier Perform Reversed Augmented Glenoid Lateralized Baseplate, 25mm, Offset +3mm, REF DWJ502

    Reason

    One lot of Tournier Perform Reversed Lateralized Baseplates were found to have been manufactured with 6mm spacers instead of 3mm spacers. This nonconformance prevents the central screw from being able to thread into the baseplate.

    Code Info

    UDI/DI 10846832062017, Lot Number 1756123

    Distribution

    US: CA, CO, IL, MA, MN, NC, OR, RI, SC, TN

    Quantity

    30 units