BEUDAMED
    FDA Enforcement Class II Ongoing

    L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7) 880-325/13 (Sz. 5-6 - cemented sm), (8) 880-325/23 (Sz. 5-6 - cemented lg), (9) 880-327/13 (Sz. 7-8 - cemented sm), (10) 880-327/23 (Sz. 7-8 - cemented lg), (11) 880-329/13 (Sz. 9-10 - cemented sm), (12) 880-329/23 (Sz. 9-10 - cemented lg).

    Recall: Z-1701-2025 · Reported May 7, 2025

    Enforcement

    Recall Number
    Z-1701-2025
    Event ID
    96643
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Waldemar Link GmbH & Co. KG (Mfg Site)
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 7, 2025
    Initiation Date
    April 3, 2025
    Classification Date
    April 30, 2025
    Address
    Oststr. 4-10, Norderstedt, N/A, Germany

    Description

    L-Shaped Femoral Augment; Item Numbers: (1) 880-320/12 (Sz. 0 - cemented sm), (2) 880-320/22 (Sz. 0 - cemented lg), (3) 880-321/12 (Sz. 1-2 - cemented sm), (4) 880-321/22 (Sz. 1-2 - cemented lg), (5) 880-323/13 (Sz. 3-4 - cemented sm), (6) 880-323/23 (Sz. 3-4 - cemented lg), (7) 880-325/13 (Sz. 5-6 - cemented sm), (8) 880-325/23 (Sz. 5-6 - cemented lg), (9) 880-327/13 (Sz. 7-8 - cemented sm), (10) 880-327/23 (Sz. 7-8 - cemented lg), (11) 880-329/13 (Sz. 9-10 - cemented sm), (12) 880-329/23 (Sz. 9-10 - cemented lg).

    Reason

    The device was delivered with a preassembled Femoral Augment screw that was missing its thread.

    Code Info

    Item Number/UDI-DI: (1) 880-320/12 (04026575258048), (2) 880-320/22 (04026575258055), (3) 880-321/12 (04026575258062), (4) 880-321/22 (04026575258079), (5) 880-323/13 (04026575258086), (6) 880-323/23 (04026575258109), (7) 880-325/13 (04026575258123), (8) 880-325/23 (04026575258147), (9) 880-327/13 (04026575258154), (10) 880-327/23 (04026575258161), (11) 880-329/13 (04026575258178), (12) 880-329/23 (04026575258185). Applies to all lots of the LINK SymphoKnee Femoral Augments listed, manufactured up until 03/01/2025.

    Distribution

    US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, IN, IL, KS, LA, MD, MO, NV, OH, TX, VA, WI.

    Quantity

    441 units