BEUDAMED
    FDA Enforcement Class II Ongoing

    OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993

    Recall: Z-0150-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0150-2021
    Event ID
    86462
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 28, 2020
    Initiation Date
    September 9, 2020
    Classification Date
    October 21, 2020
    Address
    150 Minuteman Rd, N/A, Andover, MA, 01810-1031, United States

    Description

    OSTEORAPTOR 2.3 W. UB COBRAID BLUE-Absorbable Suture anchor Product Number: 72201993

    Reason

    Product packaging improper or incomplete seal of the pouch surrounding the sterile product may result in a breach of the sterile barrier created by the pouch

    Code Info

    Batch Numbers: 2012768 2013311 2012721 2013998 2016127 2018633 2018634 2019989 2020049 2021384 2021453 2023181 2023223 2023335 2025106 2025286 2026922 2025140 2026921 2026923 2025339 2027417 2027452 2029072 2029363 2030909 2030910 2030911 2030985 2030983 2030984 2032785 2033372 2033373 2034382 2034383 2034384 2035515 2035516 2035517 2035518 2036275 2036276 2039986 2038899 2039421 2039422 2040069 2040070 2040071 2044789 2044790 2044791 2050884 2049652 2049653 2050885 2055771 2055772 2056306 2048187 2056871 2056307

    Distribution

    Nationwide Foreign: AE, AT, AU, BE, BM, BR, CA, CH, CL, CN, CO, CY, CZ, DE, DK, DO, EC, EE, ES, FI, FR, GB, GE, GR, HK, HU, IE, IL, IN, IT, JP,KR, LV,MY, NL, NO, PA,PE, PL, PR, PT, RU, SE, SG, SI, TH, TR, TW, UA, & ZA

    Quantity

    263,874 (total)