Orthosoft, Inc. dba Zimmer CAS recalls NDI P7 Position Sensor, Stereotaxic Instrument

Recall date

June 9, 2009

Source

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

Recall number

Z-2048-2017

FDA classification

Class II

Brand / firm

Orthosoft, Inc. dba Zimmer CAS

Sold / distributed

Worldwide Distribution - US Distribution to the states of : KS, MS, WI, NJ, KS, IN, LA, FL and WA., and to the countries of : Canada, Australia, Singapore, Netherlands, UK, Austria, Germany, Switzerland and Czech Republic.

Why it was recalled

Zimmer CAS voluntarily conducted a retrospective recall on specific P7 Position Sensors (Cameras), installed on Sesamoid and Sesamoid Plasty CAS workstations due to a series of these components determined to be affected with a manufacturing issue whereby they may potentially stop functioning during usage.

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

What was recalled

NDI P7 Position Sensor, Stereotaxic Instrument