BEUDAMED
    FDA Enforcement Class II Terminated

    Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture

    Recall: Z-0316-2017 · Reported November 2, 2016

    Enforcement

    Recall Number
    Z-0316-2017
    Event ID
    75142
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Aesculap Implant Systems LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 2, 2016
    Initiation Date
    August 1, 2016
    Classification Date
    October 26, 2016
    Termination Date
    February 16, 2018
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217, United States

    Description

    Safil QUI + UNDY 5/0 (1) 45CM DSMP13 Suture

    Reason

    There is a potential for the needle to detach from the suture thread during surgery. If the needle becomes detached the defective suture will need to be replaced causing the wound to be sutured a second time.

    Code Info

    Lot # 115441 Product Code C1046619

    Distribution

    Distributed in Arizona

    Quantity

    180 units