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Orthosoft, Inc. dba Zimmer CAS recalls Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of
Recalled June 14, 2017 · FDA recall Z-2227-2017 · Orthosoft, Inc.
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. · FDA Class II
Units
10
Sold at
Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil
Description
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.
Product
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
Manufacturer(s)
Orthosoft, Inc. dba Zimmer CAS
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →