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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