FDAFDA · Alimentos y medicamentos·N.º oficial Z-1816-2013
Synthes Large External Fixation, MR Conditional, Tube to Tube Clamp, Part Number 390.007, Lot Number 6800599 Synthes Large External Fixation is intended for use to provide treatment for long bone and pelvic fractures that require external fixation.
Publicado el 7 de agosto de 2013 · Inicio del retiro: 12 de octubre de 2012
Estado reportado al momento de publicación: Ongoing — openFDA actualiza semanalmente y este campo no refleja el estado más reciente. Confirma siempre con la fuente oficial.
Qué peligro representa
It was discovered internally that there was a discrepancy between the insert provided with the Tube to Tube Clamp and what was called for in the Bill of Materials. Following a detailed investigation, it was determined that the incorrect insert was used which indicates that the device is MR Safe, when it is actually MR Conditional.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Synthes USA HQ, Inc.
- Distribuidor
- US Distribution including the states of CA, MN, NC and TN.
- Lote
- Part Number 390.007, Lot Number 6800599
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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