BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 20, 2022

    Recall

    Recall Number
    Z-0150-2023
    Event Number
    90890
    Firm
    Ethicon, Inc. Us
    FEI Number
    2210968
    Product Code
    GAM
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    September 20, 2022
    Posted
    October 31, 2022
    Address
    Highway 22 West, Somerville, NJ, 08876

    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

    Action

    Ethicon notified the responsible Johnson & Johnson Affiliates in China who are contacting their impacted primary and secondary consignees and/or end customers. Translated letter dated 9/23/22. Customers are requested to return all unused impacted products that are in their inventory immediately. Returned products pertaining to this action will be segregated and destroyed by affiliates per local procedures and regulations

    Distribution

    International distribution of the country of China.

    Quantity

    2,280 eaches