BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated March 24, 2022

    Recall

    Recall Number
    Z-1053-2022
    Event Number
    90016
    Firm
    Ethicon, Inc. Us
    FEI Number
    2210968
    Product Code
    GAM
    Status
    Open, Classified
    Root Cause
    Employee error
    Initiated
    March 24, 2022
    Address
    Highway 22 West, Somerville, NJ, 08876

    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.

    Action

    A translated notification letter was mailed to customers in China on 03/24/2022. Customers are advised to no longer use or distribute recalled product. Arrange returns through your upstream distributor or Johnson & Johnson Medical (Shanghai) Ltd. All customers and sub-distributors are to complete and submit the acknowledgement form. Contact your local sales representative with questions or contact 1-877-ETHICON.

    Distribution

    International distribution in the country of China.

    Quantity

    2808 (all OUS)