MCA5-2SB - 2MM Fluted Ball, 5.6CM. All lots are included in recall. Intended for use in cutting and shaping delicate bone material, primarily in otologic procedures such as cochleostomy.
Publicado el 22 de enero de 2014 · Inicio del retiro: 29 de marzo de 2012
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 Anspach Effort, Inc. is recalling all lots of the Anspach Micro Curved Attachment (MCA) Cutting Burrs and Dissection Tools. The recall was initiated after the indications for use were found to be broader than the validation of the MCA Cutting Burrs and its directions for use did not clearly state the correct intended use of the device. After a labeling correction, Anspach Effort, Inc. decide
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- The Anspach Effort, Inc.
- Distribuidor
- Worldwide Distribution: US (nationwide) and Internationally to: AU, BE, CA, CH, ES, FR, GB, IT, JP, NL, SE, and ZA.
- Lote
- All lots are included in recall
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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