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Orthosoft, Inc. dba Zimmer CAS recalls NDI P7 Position Sensor, Stereotaxic Instrument
Recalled May 17, 2017 · FDA recall Z-2048-2017 · Orthosoft, Inc.
Hazard
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. · FDA Class II
Units
34
Sold at
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.
Description
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.
Product
NDI P7 Position Sensor, Stereotaxic Instrument
Manufacturer(s)
Orthosoft, Inc. dba Zimmer CAS
Made in
Canada
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →