BEUDAMED
    FDA Recall 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 · Initiated October 3, 2013

    Recall

    Recall Number
    Z-0202-2014
    Event Number
    66485
    Firm
    Synthes USA HQ, Inc.
    FEI Number
    3005180112
    Product Code
    LXH
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    October 3, 2013
    Posted
    November 13, 2013
    Terminated
    August 26, 2016
    Address
    1302 Wrights Ln E, West Chester, PA, 19380-3417

    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.

    Action

    Synthes sent an Urgent Notice: Voluntary Medical Device Recall Notification letters, dated October 3, 2013, to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to review their inventory and immediately remove the affected lots from stock. For questions call 610-719-5450 or contact your Synthes Sales Consultant.

    Distribution

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

    Quantity

    2979