FDAFDA · Alimentos y medicamentos·N.º oficial Z-2089-2017
GE426R; HI-LINE XS DIAMOND BURR X-CRS.I D4.5MM; GE426SU; HI-LINE XS DISP.DIAM.BURR X-CRS.I D4.5MM; GE526R; HI-LINE XS DIAMOND BURR X-CRS.II D4.5MM; GE526SU; HI-LINE XS DISP.DIAM.BURR X-CRS.II D4.5; GE626R; HI-LINE XS DIAMOND BURR X-CRS.III D4.5MM; GE626SU; HI-LINE XS DISP.DIAM.BURR X-CRS.III D4.5; Product Usage: The ELAN 4 motor system and the Hi-Line XS handpiece are intended for high speed cutting, sawing, drilling and manipulation of soft tissue and bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.
Publicado el 24 de mayo de 2017 · Inicio del retiro: 28 de marzo de 2017
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
Diamond particulates may break off the burr and fall into the surgical site. If the particles are not detected and are not removed from the surgical site a foreign body reaction may occur. These particulates could also lead to mechanically induced soft tissue damage.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Aesculap Implant Systems LLC
- Distribuidor
- US Nationwide distribution - CA, IL, NY, PA, TN, TX
- Lote
- Model numbers: GE426R ; GE426SU ; GE526R ; GE526SU ; GE626R ; GE626SU ;
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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