BEUDAMED
    FDA Recall 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 · Initiated May 15, 2014

    Recall

    Recall Number
    Z-1984-2014
    Event Number
    68383
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    HWC
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    May 15, 2014
    Posted
    July 2, 2014
    Terminated
    December 18, 2015
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    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.

    Action

    An urgent medical device recall notice, dated May 29, 2014, was sent to end users and sales consultants to advise them of the issue and provide instructions for returning affected devices.

    Distribution

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

    Quantity

    44