BEUDAMED
    FDA Recall Open, Classified

    PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles

    Recall: Z-1773-2022 · Initiated August 8, 2022

    Recall

    Recall Number
    Z-1773-2022
    Event Number
    90764
    Firm
    Ethicon, Inc. Us
    FEI Number
    2210968
    Product Code
    NEW
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    August 8, 2022
    Address
    Highway 22 West, Somerville, NJ, 08876

    Description

    PDS II (polydioxanone) Suture, Product Code Z771D 4-0 PDS Suture, Violet, 8x18" (45cm), SH-1 Control Release Needles

    Reason

    Product may contain the incorrect material which could impact treatment.

    Action

    Customer notification began August 8, 2022. The responsible Johnson & Johnson affiliates in Japan will be contacting all their impacted primary and secondary consignees and/or end customers. Customers are asked to immediately check inventory for impacted product and to quarantine that product. In the event product has been forwarded to another facility, the customer shall contact that facility to arrange return. The customer shall complete the Business Reply Form (BRF) to confirm receipt of the recall notice within 3 business days. Customers are required to return unused impacted product per the recall letter instructions.

    Distribution

    Distribution in Japan only

    Quantity

    88 boxes (1056 ea)