BEUDAMED
    FDA Enforcement Class II Ongoing

    LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).

    Recall: Z-0878-2020 · Reported February 5, 2020

    Enforcement

    Recall Number
    Z-0878-2020
    Event ID
    84559
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 5, 2020
    Initiation Date
    December 16, 2019
    Classification Date
    January 28, 2020
    Address
    1450 E Brooks Rd, N/A, Memphis, TN, 38116-1804, United States

    Description

    LEGION AP Cutting Block Size 4, REF 71434409; LEGION AP Cutting Block Size 6, REF 71434411; LEGION AP Cutting Block Size 7, REF 71434412; LEGION AP Cutting Block Size 8, REF 71434413. (Orthopaedic manual surgical instrument).

    Reason

    Multiple lots of LEGION AP Femoral Cutting Blocks were manufactured with an oversize green plunger hole and therefore do not meet their design specifications.

    Code Info

    LEGION AP Cutting Block Size 4, Product Number 71434409, Lot Numbers: 17LM05399, 17LM07852, 17LM07852A; LEGION AP Cutting Block Size 6, Product Number 71434411, Lot Numbers: 17LM05397, 17LM05398, 17LM07849; LEGION AP Cutting Block Size 7, Product Number 71434412, Lot Numbers: 17LM01746, 17LM05390, 17LM05394, 17LM07851; LEGION AP Cutting Block Size 8, Product Number 71434413, Lot Number: 17LM08442.

    Distribution

    USA: IA, NC, PA, TN. Int'l: CH, BE, GB, AE, CN, DE, NL, BR, FR.

    Quantity

    59 units