BEUDAMED
    FDA Recall Terminated

    Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.

    Recall: Z-1669-2014 · Initiated April 29, 2014

    Recall

    Recall Number
    Z-1669-2014
    Event Number
    68190
    Firm
    Synthes, Inc.
    FEI Number
    3005180112
    Product Code
    GFG
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 29, 2014
    Posted
    May 29, 2014
    Terminated
    May 19, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    Description

    Synthes ProDisc-C 2.0mm Milling Bit, Synthes 2.0mm Milling Bit HXC, Synthes 2.0mm Milling Bit with 2.35mm x 33.5mm Shaft, and Synthes 2.0mm Milling Bit with Flat Coupling. Spinal surgical instrument: The Synthes ProDisc-C 2.0mm Milling Bits are used as a part of the milling option for keel preparation of the vertebral bodies. The milling bits are coupled to a power tool and interface with the milling guide, which is connected to a trial implant for the keel preparation step.

    Reason

    Certain lots of the ProDisc-C 2.0mm Milling Bits have an increased potential to break during use.

    Action

    DePuy Synthes sent a Recall letter, dated April 29, 2014, to affected customers. The letter identified the affected customers, problem and actions to be taken. The letter instructed customers to discontinue use and distribution of the device and to return affected devices to Synthes. For questions call 610-719-5450.

    Distribution

    US Nationwide Distribution

    Quantity

    6690