FDA-Device2013-11-20Class II
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 instrume
Synthes USA HQ, Inc.
Hazard
Complaints were received for intraoperative reamer head breakages which can allow for unretrieved fragments of non-implant grade material.
Sold states
Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
Affected count
2979
Manufactured in
1302 Wrights Ln E, West Chester, PA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0202-2014Don't want to check this manually?
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