BEUDAMED
    FDA Enforcement Class II Ongoing

    TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612

    Recall: Z-0159-2021 · Reported October 28, 2020

    Enforcement

    Recall Number
    Z-0159-2021
    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

    TWINFIX ULTRA PLLA HA 4.5MM W/ NEEDLES- Absorbable Suture anchor Product Number: 72202612

    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: 2027487 2031136 2033257 2034471 2038440 2050957 2053792 2056056

    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)