FDAFDA · Alimentos y medicamentos·N.º oficial Z-0727-2014
Anspach Carbide Cutting Burrs: 1.5MMx7.5MM Cylindrical Carbide Drum part # S-15DRMC-L, 1MM Carbide Fluted ball, Extended part # S-1B-C, 1MM Carbide Fluted ball part # S-SB-C, 2MM Carbide Fluted ball part # S-2SB-C, 3MM Carbide Fluted ball Extended part # S-3B-C, 3MM Carbide Fluted ball part # S-3SB-C, 4MM Carbide Fluted ball part # S-4B-C, 4MM Carbide Fluted ball Extended 27MM part # S-4BL-C, 5MM Carbide Fluted ball part # S-5B-C, and 6MM Carbide Fluted ball part # S-6B-C. Anspach cutting burrs are intended for cutting and shaping bone, including the spine and cranium
Publicado el 22 de enero de 2014 · Inicio del retiro: 17 de diciembre 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
Some carbide cutting burr fractured during use.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- The Anspach Effort, Inc.
- Distribuidor
- Worldwide distribution: US (Nationwide) including state of Hawaii and Internationally to: Australia, Poland, Canada, South Africa, Israel, and Switzerland.
- Lote
- All Lot numbers distributed within the 5 years expiration date (12/13 thru 10/18)
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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