This event has been recorded by zimmer biomet under cmp (b)(4).Review of the most recent repair record determined the device was out of calibration at the zero setting, the rpms did not meet specification, the motor, bearings, reciprocating arm, control bar, and head were replaced and device calibrated and resolved the reported issue.Device is used for treatment.A definitive root cause cannot be determined.No corrective actions, preventive actions, or field actions resulted after investigation of this event.The event cannot be confirmed.
|