BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated December 16, 2019

    Recall

    Recall Number
    Z-0878-2020
    Event Number
    84559
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    MBH
    Status
    Open, Classified
    Root Cause
    Process change control
    Initiated
    December 16, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    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.

    Action

    The firm initiated the recall by letter on December 16, 2019. The letter identified the problem and directed the consignee to remove the affected lots noted in the Urgent Medical Device Recall Notice.

    Distribution

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

    Quantity

    59 units