BEUDAMED
    FDA Recall Terminated

    Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

    Recall: Z-1103-2021 · Initiated January 8, 2021

    Recall

    Recall Number
    Z-1103-2021
    Event Number
    87189
    Firm
    DePuy Orthopaedics, Inc.
    FEI Number
    1818910
    Product Code
    JWH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    January 8, 2021
    Terminated
    January 17, 2024
    Address
    700 Orthopaedic Dr, Warsaw, IN, 46582-3994

    Description

    Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

    Reason

    The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

    Action

    On 01/12/2021, DePuy Synthes issued an Urgent Medical Device Recall (removal) via letter due to taper dimensions of certain Universal Femoral Sleeves may be out of specification. The Universal Femoral Sleeves are used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. DePuy is recommending that customers return the recalled devices.

    Distribution

    Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.

    Quantity

    60 sleeves