Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the track...
FDA Recall #Z-2227-2017 — Class II — June 4, 2008
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.
Recalling Firm
Orthosoft, Inc. dba Zimmer CAS — Montreal, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
10
Distribution
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated