FDAFDA · Alimentos y medicamentos·N.º oficial Z-0415-2013
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The shell utilizes a modular polyethylene liner and a femoral head component that is taper fit onto a femoral stem at the time of surgery. Cemented or non-cemented total hip replacement . The device is intended for general use in skeletally mature individuals undergoing primary and/or secondary revision surgery at high risk of hip dislocation due to a history of prior dislocation, joint or bone loss, soft tissue laxity, neuromuscular disease, or intra-operative instability and for whom all other options to constrained acetabular components have been considered
Publicado el 28 de noviembre de 2012 · Inicio del retiro: 4 de octubre 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
The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)
Qué hacer
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Detalles del retiro
- Fabricante
- Biomet, Inc.
- Distribuidor
- Nationwide Distribution including CA, IN, NC, OH, and UT.
- Lote
- Part 11-106054 Lot 528310
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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