BEUDAMED
    FDA Enforcement Class II Terminated

    1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201

    Recall: Z-1334-2020 · Reported February 26, 2020

    Enforcement

    Recall Number
    Z-1334-2020
    Event ID
    84772
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2020
    Initiation Date
    August 28, 2019
    Classification Date
    February 20, 2020
    Termination Date
    February 11, 2021
    Address
    Us Highway 22 West, Somerville, NJ, 08876, United States

    Description

    1 STRATAFIX Spiral PDS Plus Violet 18" (45cm) OS-6 Needle, SXPP1B201

    Reason

    The product do not meet certain internal testing specifications.

    Code Info

    GTIN: 10705031235861 Lot Number: PAH360 Expiration Date: 12/31/2020

    Distribution

    International: Australia, Hong King, India, Japan, Korea, Singapore, Thailand

    Quantity

    3 units