FDAFDA · Alimentos y medicamentos·N.º oficial Z-0411-2014
Shortened Plug Driver; Low Volume Specialty Device; Qty:1; Rx Only; Non Sterile; Biomet Spine, Parsippany, NJ 07054 The Polaris Spinal Systems is a non-cervical spinal fixation device intended for immobilization and stabilization as an adjunct to fusion as a pedical screw fixation system, a posterior hook and sacral/iliac screw fixation system, or as an anterior or anterolateral fixation system. Pedicle screw fixation is limited to skeletal mature patients for use with autograft and/or allograft. The device is indicated for all the following indications:degenerative disc disease (defined as discogeneic back pain with degeneration of the disk confirmed by history and radiographic studies), spondylolisthesis, and or lordosis) tumor, stenosis, pseudoarthrosis, or failed previous fusion
Publicado el 4 de diciembre de 2013 · Inicio del retiro: 24 de septiembre 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
Biomet received a complaint on 5/20/2013 reporting that the tip of the instrument sheared off during a removal case.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Ebi, Llc
- Distribuidor
- US Distribution to CA
- Lote
- Device listing # D090878 Catalog # LV00407 Lot #184090
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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