BEUDAMED
    FDA Enforcement Class II Ongoing

    STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

    Recall: Z-1053-2022 · Reported May 18, 2022

    Enforcement

    Recall Number
    Z-1053-2022
    Event ID
    90016
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 18, 2022
    Initiation Date
    March 24, 2022
    Classification Date
    May 10, 2022
    Address
    Us Highway 22 West, N/A, Somerville, NJ, 08876, United States

    Description

    STRATAFIX SPIRAL PGA-PCL UNI UD sizes: [20CM USP2-0(M3) S/A RB-1, product code: SXMD1B403-12] and [30CM USP2-0(M3) S/A PS-1, product code: SXMD1B100-12].

    Reason

    Affected product lots may contain the incorrect needle type/size and suture length due to component mix-up.

    Code Info

    Lot AAHM529, UDI(01)10705031228054(20)12(17)260331(10)AAHM529 Lot AAHQ049, UDI (01)10705031228047(20)12(17)260430(10)AAHQ049

    Distribution

    International distribution in the country of China.

    Quantity

    2808 (all OUS)