FDA-Device2017-04-26Class II

SmartTools Knee System Orthopedic Stereotaxic Instrument

Orthosoft, Inc. dba Zimmer CAS
Hazard

There has been an increase in the number of complaints regarding bent or broken Drive Pins of the Validation Tool manufactured with drawing Revision M to P

Sold states
Nationwide Distribution
Affected count
84
Manufactured in
75 Queen St #3300, N/A, Montreal, N/A, Canada
Products
SmartTools Knee System Orthopedic Stereotaxic Instrument

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1868-2017

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