BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-0316-2017 · Initiated August 1, 2016

    Recall

    Recall Number
    Z-0316-2017
    Event Number
    75142
    Firm
    Aesculap Implant Systems LLC
    FEI Number
    2916714
    Product Code
    GAM
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    August 1, 2016
    Terminated
    February 16, 2018
    Address
    3773 Corporate Pkwy, Center Valley, PA, 18034-8217

    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.

    Action

    An Urgent Medical Device Recall Notification Letter was mailed to customers on August 11, 2016 asking them to remove and return the affected product immediately.

    Distribution

    Distributed in Arizona

    Quantity

    180 units