BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

    Recall: Z-0681-2017 · Reported December 7, 2016

    Enforcement

    Recall Number
    Z-0681-2017
    Event ID
    75694
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes (USA) Products LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 7, 2016
    Initiation Date
    November 1, 2016
    Classification Date
    December 1, 2016
    Termination Date
    June 1, 2017
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986, United States

    Description

    Synthes 0.76 mm Drill Bit/Stryker J-Latch/with 5mm Stop/44.5 mm Non-Sterile

    Reason

    Package may be incorrectly labeled as containing 0.76 mm Drill Bit, but in fact contain a 1.1 mm diameter Drill Bit.

    Code Info

    Model/Catalog # 316.15 Lot/Serial Number U172728

    Distribution

    Distributed Nationwide

    Quantity

    84 units