BEUDAMED
    FDA Recall Terminated

    8.5mm Reamer Head for Flexible Intramedullary Nailing System; 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, burr, 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-2359-2015 · Initiated July 1, 2015

    Recall

    Recall Number
    Z-2359-2015
    Event Number
    71729
    Firm
    Synthes (USA) Products LLC
    FEI Number
    3008812560
    Product Code
    HTO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 1, 2015
    Posted
    August 10, 2015
    Terminated
    August 26, 2016
    Address
    1301 Goshen Pkwy, West Chester, PA, 19380-5986

    Description

    8.5mm Reamer Head for Flexible Intramedullary Nailing System; 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, burr, 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

    The possibility exists for intraoperative reamer head breakages which could also allow for un-retrieved fragments of non-implant grade material: additional lot numbers identified. No new adverse events reported.

    Action

    An urgent notice of medical device recall, dated July 1, 2015, was sent to end users and sales consultants to alert them about the device defect and potential risk to patients. Recipients were asked to complete the verification form and return it along with any affected devices their posession.

    Distribution

    Worldwide Distribution.

    Quantity

    4329