FDA Recall
Terminated
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Recall: Z-0160-2018
·
Initiated November 6, 2014
Recall
- Recall Number
- Z-0160-2018
- Event Number
- 77626
- Firm
- Zimmer Biomet, Inc.
- FEI Number
- 1000220733
- Product Code
- HAW
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- November 6, 2014
- Terminated
- July 13, 2020
- Address
- 1800 W Center St, Warsaw, IN, 46580-2304
Description
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Reason
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Action
All 9 domestic units were corrected by the firm in February 2017, via technician visits to consignee sites.
Distribution
US distribution in AR, GA, OH, MI, and TX.
Quantity
31 units