FDAFDA · Alimentos y medicamentos·N.º oficial Z-1415-2013
12mm x 27mm x 8mm 12mm x 27mm x 9mm 12mm x 27mm x 10mm 12mm x 27mm x 11mm 12mm x 27mm x 12mm 12mm x 27mm x 13mm 12mm x 27mm x 14mm 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 # 10227-008 10227-009 10227-010 10227-011 10227-012 10227-013 10227-014
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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