FDAFDA · Alimentos y medicamentos·N.º oficial Z-0542-2015
Cushing perforating drills are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the Boss Instruments, Symmetry Surgical, Medfix International, Stealth Surgical, and CareFusion brand names.
Publicado el 17 de diciembre de 2014 · Inicio del retiro: 8 de septiembre de 2014
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
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Instrumed International, Inc.
- Distribuidor
- Nationwide Distribution including AZ, CA, FL, IL, KS, MI, NC, OH, PA, TN, TX, and VA.
- Lote
- 1) Instrumed Product Name: Cushing Perforating, Drill, 3/8", 10 mm; Instrumed Product Number: 600-00509; Trade Name: Boss Industries; Boss Industries Product Name: Cushing Perforating, Drill, 3/8", 10 mm; Boss Industries Item Number: 74-0100; Lot Number: 110211. 2) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: Symmetry Surgical; Symmetry Surgical Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Symmetry Surgical Item Number: 57-6034; Lot Number: 060212. 3) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: Medfix International; Medfix International Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Medfix International Item Number: MF223-1577; Lot Number: 060212. 4) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: Stealth Surgical; Stealth Surgical Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Stealth Surgical Item Number: SS2122; Lot Number: 060212. 5) Instrumed Product Name: Cushing Perforating, Drill, 1/2", 13 mm; Instrumed Product Number: 600-00514; Trade Name: CareFusion; CareFusion Product Name: Cushing Perforating, Drill, 1/2", 13 mm; CareFusion Item Number: VM85-1213; Lot Number: 060212, 110313.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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