FDAFDA · Alimentos y medicamentos·N.º oficial Z-1418-2013
Fang Screw 20mm Fang Plate 21mm Product Usage: Spinal Solutions distributes a variety of spinal fixation devices in loaner bins or on consignment. The company has decided to provide directions for use and surgical techniques electronically on the companys website. The company has created a label intended to inform the user of the existence of the websites and the information it contains. Indications for use: multiple.
Publicado el 5 de junio de 2013 · Inicio del retiro: 20 de febrero 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 recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Spinal Solutions, LLC
- Distribuidor
- USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
- Lote
- Item # FP1220 FP1221
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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