Catalog Number 3572-1 |
Device Problem
Calibration Problem (2890)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 07/23/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Udi number: ni.Current information is insufficient to permit a valid conclusion about the cause of this event.A follow up report will be sent upon completion of the device evaluation.
|
|
Event Description
|
It was reported that the torque output of a torque limiting handle was found outside of the adequate performance range.This was detected during a preliminary calibration check by zimmer biomet spine personnel.There are no specific surgical procedures associated with this handle.
|
|
Manufacturer Narrative
|
Udi: (b)(4).The returned device was evaluated; it was found to meet specifications, so no device problems were detected.A review of the manufacturing records did not identify any issues which may have contributed to this event.
|
|
Event Description
|
It was reported that the torque output of a torque limiting handle was found outside of the adequate performance range.This was detected during a preliminary calibration check by zimmer biomet spine personnel.There are no specific surgical procedures associated with this handle.
|
|
Search Alerts/Recalls
|