FDAFDA · Alimentos y medicamentos·N.º oficial Z-1939-2012
Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on the side of the needle.
Publicado el 11 de julio de 2012 · Inicio del retiro: 4 de mayo 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
Additional Instructions for Use and Surgical Technique for the Confidence Needle due to reports of breakage with the side fire needles
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Distribuidor
- Worldwide Distribution-USA (nationwide) and the countries of Canada, Austria, China, Croatia, Czech Republic, France, Germany, Greece, Hungary, Italy, Lebanon, Netherlands, New Zealand, Poland, Russian Federation, Singapore, South Africa, Spain, Switzerland, Turkey, UAE, and UK.
- Lote
- All lots
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States