FDAFDA · Alimentos y medicamentos·N.º oficial Z-2227-2017
Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of the software based navigation systems. The affected Sesamoid Plasty components are the central structural column and its base that hold up the computer and the tracking camera on the Sesamoid Plasty workstation. They are also designed to be disassembled such that the column can be folded onto itself for ease of transport after use. This is a retrospective recall report for a removal initiated on 17 June 2008
Publicado el 14 de junio de 2017 · Inicio del retiro: 4 de junio de 2008
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
Zimmer CAS voluntarily conducted a retrospective recall of the Sesamoid Plasty due to the risk of the top of the workstation to potentially fall over during disassembly.
Qué hacer
Voluntary: Firm initiated · Letter
Detalles del retiro
- Fabricante
- Orthosoft, Inc. dba Zimmer CAS
- Distribuidor
- Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil
- Lote
- Part Number and : 521.025/521.028; Lot Number/Serial Numbers: SP-001, SP-002, SP-003, SP-004, SP-005, SP-006, SP-007, SP-008, SP-009, SP-010
- Clasificación de riesgo
- Class II
- Área (FDA)
- device
- País
- Canada
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