BEUDAMED
    FDA Enforcement Class II Ongoing

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

    Recall: Z-1773-2022 · Reported September 28, 2022

    Enforcement

    Recall Number
    Z-1773-2022
    Event ID
    90764
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 28, 2022
    Initiation Date
    August 8, 2022
    Classification Date
    September 20, 2022
    Address
    Us Highway 22 West, N/A, Somerville, NJ, 08876, United States

    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.

    Code Info

    UDI-DI (GTIN): 10705031061705 (individual unit); 30705031061709 (sales unit box) Product Number: Z771D; Lot No: SAMPAL

    Distribution

    Distribution in Japan only

    Quantity

    88 boxes (1056 ea)