BEUDAMED
    FDA Enforcement Class II Ongoing

    BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

    Recall: Z-0581-2025 · Reported December 11, 2024

    Enforcement

    Recall Number
    Z-0581-2025
    Event ID
    95654
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Report Date
    December 11, 2024
    Initiation Date
    October 29, 2024
    Classification Date
    November 29, 2024
    Address
    150 Minuteman Rd, Andover, MA, 01810-1031, United States

    Description

    BIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.

    Reason

    Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.

    Code Info

    Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.

    Distribution

    Worldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.

    Quantity

    2,156 units