Device product

SmartTools Knee System Orthopedic Stereotaxic Instrument

Z-1868-2017

February 20, 2017

Class II

Product summary

Firm: Orthosoft, Inc. dba Zimmer CAS
Event: Event 76508
Status: Terminated
Classification: Class II
Quantity: 84
Official record key: device-enforcement:Z-1868-2017

Official wording

Reason: 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

Code information: Lots: 130542A1 1405941 140146 140146-1 140147 140407A 140407A-1 140407B 140407-B-1 140860 140860-1 141035 150120 B150120 B150711

Distribution pattern: Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

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