BEUDAMED
    FDA Enforcement Class II Ongoing

    STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12

    Recall: Z-0150-2023 · Reported November 9, 2022

    Enforcement

    Recall Number
    Z-0150-2023
    Event ID
    90890
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 9, 2022
    Initiation Date
    September 20, 2022
    Classification Date
    October 31, 2022
    Address
    Us Highway 22 West, N/A, Somerville, NJ, 08876, United States

    Description

    STRATAFIX SPIRAL PGA-PCL UNI UD 20CM USP2-0(M3) S/A SH. indicated for use in soft tissue approximation where the use of absorbable sutures is appropriate. Product No.: SXMD1B405-12

    Reason

    Packages may contain a PS-1 cutting edge needle and not the intended SH taper point needle may result in more tissue trauma than is anticipated for taper point needles, which may necessitate repair

    Code Info

    UDI-DI: 10705031228061 Lot/Serial No.: B903HPU Expiry Date: 08/21/2026

    Distribution

    International distribution of the country of China.

    Quantity

    2,280 eaches