FDAFDA · Alimentos y medicamentos·N.º oficial Z-0557-2015
Cloward Spanner gauges are bone cutting and drilling instruments that are used without a power source on a patient's skull and sold under the CareFusion and Boss Instruments 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The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to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: Cloward Spanner Gauge, Small 5 1/8"; Instrumed Product Number: 650-11864; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Small 5 1/8"; Boss Instruments Item Number: 74-1448; Lot Number: 070412. 2) Instrumed Product Name: Cloward Spanner Gauge, Small 5 1/8"; Instrumed Product Number: 650-11864; Trade Name: CareFusion; CareFusion Product Name: Cloward Spanner Gauge, Small 5 1/8"; CareFusion Item Number: VM85-2559; Lot Number: 070412. 3) Instrumed Product Name: Cloward Spanner Gauge, Large 5 1/8"; Instrumed Product Number: 650-11869; Trade Name: Boss Instruments; Boss Instruments Product Name: Cloward Spanner Gauge, Large 5 1/8"; Boss Instruments Item Number: 74-1449; Lot Number: 070412.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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