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FDAFDA · Alimentos y medicamentos·N.º oficial Z-0202-2014

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.

Publicado el 20 de noviembre de 2013 · Inicio del retiro: 3 de octubre de 2013

Estado reportado al momento de publicación: Terminated — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.

Qué peligro representa

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

Qué hacer

Voluntary: Firm initiated · Letter

Detalles del retiro

Fabricante
Synthes USA HQ, Inc.
Distribuidor
Worldwide Distribution: USA (Nationwide) and countries of: Canada and Mexico.
Lote
Part No. 352.085 with lot numbers 20141 through 24510, and 4399543 through 5870257
Clasificación de riesgo
Class II
Área (FDA)
device
País
United States

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