ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Reported: November 29, 2017 Initiated: November 6, 2014 #Z-0160-2018
Product Description
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Reason for Recall
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 31 units
- Distribution
- US distribution in AR, GA, OH, MI, and TX.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.. Recalled by Zimmer Biomet, Inc.. Units affected: 31 units.
Why was this product recalled? ▼
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 29, 2017. Severity: Moderate. Recall number: Z-0160-2018.
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