FDAFDA · Alimentos y medicamentos·N.º oficial Z-1726-2013
Synthes CMF Distraction System The product is intended for use as a bone stabilizer and lengthening (and/or transport) device for correction of congenital deficiencies or post-traumatic defects of the mandibular body and ramus, where gradual bone distraction is required. It is intended for single use only.
Publicado el 24 de julio de 2013 · Inicio del retiro: 12 de junio 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
The firm initiated a voluntary recall of the BC Distractor Body which is part of the Craniomaxillofacial (CMF) Distractor System, due to a mis-alignment issue. There have been instances reported within the impacted lots in which the slot in the barrel of the BC distractor was rotated such that it was not possible to attach the B-type and C-type foot plates.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Synthes USA HQ, Inc.
- Distribuidor
- Nationwide Distribution including PA, CT, DE, and NY.
- Lote
- Part # 04.315.067 with lot #s 6184270 and/or 22612-04.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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