BEUDAMED
    FDA Recall Terminated

    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

    Recall: Z-1904-2018 · Initiated March 30, 2018

    Recall

    Recall Number
    Z-1904-2018
    Event Number
    79875
    Firm
    Smith & Nephew, Inc.
    FEI Number
    1020279
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Packaging process control
    Initiated
    March 30, 2018
    Terminated
    August 21, 2019
    Address
    1450 E Brooks Rd, Memphis, TN, 38116-1804

    Description

    smith&nephew LEGION(R) CR XLPE HIGH LEXION Articular Insert, 5-6 Size, 10 MM, REF 71453185 designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact.

    Reason

    The affected products were inadvertently packaged with the inner packaging pouch being sealed together with the outer pouch.

    Action

    The firm initiated the recall by letter on 03/30/2018. The consignee was direct to return any recalled devices.

    Distribution

    US, Canada, Great Britain, Australia, Italy, Germany, Malaysia, Singapore

    Quantity

    16 units