Z-2227-2017 Class II Terminated
FDA device recall Z-2227-2017 was initiated by Orthosoft, Inc. dba Zimmer CAS on June 4, 2008 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated June 2, 2017). Affected quantity: 10.
Recall Details
- Product Type
- Devices
- Report Date
- June 14, 2017
- Initiation Date
- June 4, 2008
- Termination Date
- June 2, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product 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
Reason for Recall
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.
Distribution Pattern
Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil
Code Information
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