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
Enforcement
- Recall Number
- Z-2227-2017
- Event ID
- 75609
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Orthosoft, Inc. dba Zimmer CAS
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- June 14, 2017
- Initiation Date
- June 4, 2008
- Classification Date
- June 2, 2017
- Termination Date
- June 2, 2017
- Address
- 75 Queen St #3300, N/A, Montreal, N/A, N/A, Canada
Description
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
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.
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
Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil
10