Zimmer Biomet Recalls ROSA Surgical Device Due to Optical Sensor Failure
Zimmer Biomet is recalling 14 ROSA Surgical Devices because a cable disconnection may cause the optical distance sensor to fail.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a potential failure of a critical sensor in a surgical device, which poses a risk of harm, but the source text does not report any injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling 14 units of the ROSA Surgical Device 2.5.8. This computer-controlled electromechanical arm is intended for use in the operating room by neurosurgeons to guide standard neurosurgical instruments. The devices were distributed in the United States (including Ohio and Michigan) and internationally to Canada, China, France, Germany, and Italy.
The recall is due to a potential failure of the optical distance sensor caused by cable disconnection. The specific units affected are identified by serial numbers RO10011 and RO10014. The source text does not report any injuries or illnesses associated with this defect.
Healthcare facilities and users should contact Zimmer Biomet, Inc. for instructions on how to resolve the issue. The source text does not specify a particular action for consumers, as this is a professional medical device.
The recalled product
- Product
- ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 14
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Serial No. RO10011 and RO10014
Distribution
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