FDA-Device2017-05-17Class II
NDI P7 Position Sensor, Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
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.
Sold states
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.
Affected count
34
Manufactured in
75 Queen St #3300, N/A, Montreal, N/A, Canada
Products
NDI P7 Position Sensor, Stereotaxic Instrument
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2048-2017Don't want to check this manually?
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