BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.

    Recall: Z-1984-2014 · Reported July 9, 2014

    Enforcement

    Recall Number
    Z-1984-2014
    Event ID
    68383
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 9, 2014
    Initiation Date
    May 15, 2014
    Classification Date
    July 2, 2014
    Termination Date
    December 18, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes B37 Replacement Screws. M3.5 Screw for insertion handle guide/aiming arm, part numbers 3.113.025 and 03.113.026. Surgical instrument for use with Low Bend Medial Distal Tibia Plate. Orthopedic.

    Reason

    All lots of B37 Replacement Screws are being recalled due to potential mislabeling where the package may not contain the screws identified on the label.

    Code Info

    All lots of part no. B37: 6350586, 6771518, 7086318, 7386422, 7523960, and 7548937.

    Distribution

    Distributed US nationwide, in DC and the states of KY, PA, IL, WA, AZ, CA, OK, FL, and KS.

    Quantity

    44