FDAFDA · Alimentos y medicamentos·N.º oficial Z-1199-2017
6-hole Pubic Symphysis plate (PN 70-0451). The pelvic bone plates for the pelvic ring are a series of plates with varying lengths that function as internal fixation devices for fractures, fusions and osteotomies of the pelvic ring. The plates are strategically pre-contoured where beneficial to the application, and they are secured to the bone with 3.5mm non-locking screws. The Acumed pelvic ring plate is the Pubic Symphysis Plate. The Acumed Pelvic Plating System is intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fixation. The device is to be implanted by the surgeon in a sterile operating room setting.
Publicado el 22 de febrero de 2017 · Inicio del retiro: 19 de enero 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
The 6-hole Pubic Symphysis plate (PN 70-0451) is specified to be made of Commercially Pure Titanium (ASTM F67 - CP Grade 4). However, batch 383813 was manufactured out of Titanium Alloy (Ti-6Al- 4V ELI per ASTM F135 Ti alloy) and was distributed.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Acumed LLC
- Distribuidor
- Worldwide Distribution - Costa Rica, Malaysia, Mexico, South Africa, and Spain
- Lote
- Lot number: 383813
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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