BEUDAMED
    FDA Recall Terminated

    3.0 mm Guide Rod/950 mm with Smooth Tip, sterile

    Recall: Z-0640-2017 · Initiated October 3, 2016

    Recall

    Recall Number
    Z-0640-2017
    Event Number
    75502
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    October 3, 2016
    Posted
    November 19, 2016
    Terminated
    July 6, 2017
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    3.0 mm Guide Rod/950 mm with Smooth Tip, sterile

    Reason

    The peel pouches for the affected reaming rods and extraction hooks are delaminating.

    Action

    DePuy Synthes mailed a Customer Safety Advisory Notice on October 19, 2016 to affected customers advising them of the malfunction, potential risks and the actions needed to be taken to avoid injury, as they work on a solution to correct the problem.

    Distribution

    Distributed Nationwide

    Quantity

    319 units