Zimmer Biomet Recalls ROSA Surgical Device Software
Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue affecting cooperative endoscopy mode.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, which typically involves a temporary or medically reversible adverse health consequence. The source text does not report any injuries, illnesses, or deaths, and the issue is a software correction rather than a structural defect or high-risk pathogen.
Plain-English summary
Zimmer Biomet, Inc. is recalling 29 units of the ROSA Surgical Device 2.5.8. The device is intended for use in the operating room by neurosurgeons to guide standard neurosurgical instruments using spatial positioning and orientation.
The recall is being conducted to implement software corrections that reactivate the cooperative endoscopy mode. The affected devices were distributed worldwide, including in the United States (Arkansas, Georgia, Michigan, Ohio, and Texas) and in Canada, China, France, Germany, Israel, Italy, Russia, Saudi Arabia, and Spain.
Healthcare facilities should contact Zimmer Biomet for instructions on how to obtain the software corrections. The recall involves specific serial numbers listed in the official FDA notice.
The recalled product
- Product
- 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. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial marker
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
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 (20)
- Serial No. RO10011
- RO14033
- RO14031
- RO14035
- RO13027
- RO13023
- RO10014
- RO10009
- RO10010
- RO14030
- RO11016
- RO11017
- RO12022
- RO14029
- RO14032
- RO08003
- RO09004
- RO10007
- RO10013
- RO12018
Distribution
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