Orthosoft, Inc. dba Zimmer CAS recalls Sesamoid Plasty, Stereotaxic Instrument The Sesamoid Plasty workstation is used to run the tracking software as part of…

Recall date

June 4, 2008

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-2227-2017

FDA classification

Class II

Brand / firm

Orthosoft, Inc. dba Zimmer CAS

Sold / distributed

Worldwide Distribution - US including FL, CA Foreign: Austrailia, New Zealand, France, Brazil

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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