Home / Recalls / Medical Devices
Synthes USA HQ, Inc. recalls Synthes 8.5 MM Medullary Reamer Product Usage: An orthopedic manual surgical instrument is a nonpowered hand-held d
Recalled November 20, 2013 · FDA recall Z-0202-2014 · Synthes USA HQ
Hazard
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material. · FDA Class II
Units
2979
Sold at
Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
Description
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Product
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.
Manufacturer(s)
Synthes USA HQ, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →