S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage: Surgical Guides allow a surgeon to place implants into tight spaces, such as a vertebral disc space, without having the implant contact the surrounding bone or tissue. In the case of S-LIFT Implant Guides, they are used to place vertebral bodies into the disc space without the body contacting the superior or inferior vertebrae.
Publicado el 28 de noviembre de 2012 · Inicio del retiro: 22 de agosto 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
When using the optional S-LIFT (also known as S-LIF) Implant Guides without stops, there is a known risk of moving the Implant Guides, and possibly the implant, too far into the disc space creating the potential for injury to the patient. The instructions for Use for the S-Lift Implant Guides will be amended to add the following warning: "Care is to be taken to not over insert the Implant Guides
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- SpineFrontier, Inc.
- Distribuidor
- US Nationwide including the states of: MA and TX.
- Lote
- Lot Numbers: 012064-001
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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