BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.

    Recall: Z-0986-2014 · Reported February 26, 2014

    Enforcement

    Recall Number
    Z-0986-2014
    Event ID
    67390
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 26, 2014
    Initiation Date
    January 27, 2014
    Classification Date
    February 16, 2014
    Termination Date
    December 18, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes 3.2 mm Guide Wire 400mm. Used for guiding the TFN Helical Blade and TFN Lag Screw into the femoral.

    Reason

    Synthes 3.2 mm Guide Wire 400mm included an incorrect raw material listed on the label.

    Code Info

    part No. 357.399 with all lot numbers 4440270 through 49991803, 5000218 through 5894644, 6000409 through 6999404, 7000143 through 7531836, UK09636, UK10233, UK10510, UL11099, and UL11333.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Canada and Switzerland.

    Quantity

    1,132,096