FDA Recall
Terminated
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
Recall: Z-0102-2018
·
Initiated February 14, 2014
Recall
- Recall Number
- Z-0102-2018
- Event Number
- 78372
- Firm
- Zimmer Biomet, Inc.
- FEI Number
- 1000220733
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- February 14, 2014
- Terminated
- September 16, 2020
- Address
- 1800 W Center St, Warsaw, IN, 46580-2304
Description
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
Reason
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Action
There were 4 units imported into the US and all have been corrected.
Distribution
OH, MI and TX
Quantity
21 (4 US and 17 OUS)