BEUDAMED
    FDA Enforcement Class II Ongoing

    OSTEORAPTOR 2.3 W 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991

    Recall: Z-0148-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0148-2021
    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 1UB II BLUE-Absorbable Suture anchor Product Number: 72201991

    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: 2012767 2013997 2016120 2017772 2018792 2019839 2021494 2022257 2024709 2025285 2027451 2027481 2030907 2030908 2031041 2033235 2033236 2034376 2034377 2034378 2035450 2036270 2049647 2049648 2053756 2049649 2050880 2050881 2056052 2056053

    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)