BEUDAMED
    FDA Enforcement Class II Ongoing

    HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801

    Recall: Z-0173-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0173-2021
    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

    HEALICOIL RSB SA 5.5MM W/1 UT & 1 UB BL- Absorbable Suture anchor Product Number: 72203801

    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: 2013918 2016156 2017774 2018804 2021456 2023227 2024815 2025049 2027438 2029400 2029401 2033291 2033290 2034431 2034432 2034499 2034500 2034501 2034502 2035698 2037194 2039456 2045894 2048429 2048430 2051045 2051046 2049950 2049951 2053927 2056086 2056434

    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)