FDAFDA · Alimentos y medicamentos·N.º oficial Z-1780-2014
Stryker 3.0mm x 3.8mm Neuro Drill Less Aggressive Sterile Product Usage: The devices are intended to be used to cut bone and bone related tissue during neurosurgery, including craniotomy and spinal surgery as well as ear, nose and throat (ENT), orthopedic, and general surgical applications including maxillofacial, craniofacial surgeries. The main procedures/conditions in which these products are expected to be used are Mastoidectomy/Cochlear implant, Craniotomy, Vertebral Fusion and Fixation and Craniosynostosis.
Publicado el 18 de junio de 2014 · Inicio del retiro: 22 de mayo de 2014
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
There may be missing notches, partial notches or no notches at all in some Cutting Accessories that are used with the Elite" Attachments.
Qué hacer
Voluntary: Firm initiated
Detalles del retiro
- Fabricante
- Stryker Instruments Div. of Stryker Corporation
- Distribuidor
- Worldwide Distribution - US (nationwide)
- Lote
- Part Number 5820-107-430S1, Lot Number 14003017,14005017
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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