FDAFDA · Alimentos y medicamentos·N.º oficial Z-1127-2013
The Oxford Partial Knee; Oxford Knee Resection Procedure 3 Pack CEMENTED For use with Stryker System 5, System 4, System 2000 and EDH. Product Usage: For use with Stryker System 5, System 4, System 2000 and EDH. A set of three surgical saw blades is used to resect damaged cartilage and/or bone in an orthopedic reconstructive procedure such as a partial knee replacement. The set contains both oscillating blades for tissue resection along a small arc in a left/right or up/down direction, and reciprocating blades for resection back and forth in a single plane.
Publicado el 24 de abril de 2013 · Inicio del retiro: 14 de marzo 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 part # 506076, lot 928182 was received from Synvasive Technology containing the incorrect blade.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Synvasive Technology Inc
- Distribuidor
- USA Nationwide Distributor including the state of IN
- Lote
- Biomet Product code: 506076, Lot 829182. Synvasive Part Number: 11-3629.
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- United States
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