BEUDAMED
    FDA Enforcement Class II Terminated

    Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

    Recall: Z-0202-2014 · Reported November 20, 2013

    Enforcement

    Recall Number
    Z-0202-2014
    Event ID
    66485
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Synthes USA HQ, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2013
    Initiation Date
    October 3, 2013
    Classification Date
    November 12, 2013
    Termination Date
    August 26, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417, United States

    Description

    Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. This generic type of device includes the cerclage applier, awl, bender, drill brace, broach, bmT, corkscrew, countersink, pin crimper, wire cutter, prosthesis driver, extractor, file, fork, needle holder, impactor, bending or contouring instrument, compression instrument, passer, socket positioner, probe, femoral neck punch, socket pusher, reamer, rongeur, scissors, screwdriver, bone skid, staple driver, bone screw starter, surgical stripper, tamp, bone tap, trephine, wire twister, and wrench.

    Reason

    Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.

    Code Info

    Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257

    Distribution

    Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.

    Quantity

    2979