BEUDAMED
    FDA Enforcement Class II Terminated

    STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture

    Recall: Z-0048-2020 · Reported October 16, 2019

    Enforcement

    Recall Number
    Z-0048-2020
    Event ID
    83715
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Ethicon, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 16, 2019
    Initiation Date
    August 13, 2019
    Classification Date
    October 4, 2019
    Termination Date
    February 11, 2021
    Address
    Us Highway 22 West, N/A, Somerville, NJ, 08876, United States

    Description

    STRATAFIX Spiral PDS Plus Violet 27 (70cm) CTX Needle Product code: SXPP1B401 suture

    Reason

    The product does not meet certain internal strength testing specifications.

    Code Info

    Lot # MMH401 GTIN: 10705031236042

    Distribution

    States: IN MD AR IL GA TN NJ PA NC CA OK CO KS UT KY WA OH OR OUS: Australia Hong King India Japan Korea Singapore Thailand United States

    Quantity

    852 each