FDAFDA · Food and drugs·Recall number 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
Published June 14, 2017 · Recall initiated: June 4, 2008
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Orthosoft, Inc. dba Zimmer CAS
- Distributor
- Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil
- Lot
- 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
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Canada
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