Zimmer Biomet Recalls ROSA Surgical Device Due to Software Issue
Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue in the MXTTOUT controller parameter settings.
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, but the source text does not report any hospitalizations, injuries, or illnesses, and the hazard is described as a software issue that has been corrected, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Zimmer Biomet, Inc. is recalling 29 units of the ROSA Surgical Device 2.5.8. The device is a computer-controlled electromechanical arm intended for use in the operating room by neurosurgeons to guide standard neurosurgical instruments. The recall involves 8 units in the United States and 21 units outside the United States.
The recall is due to a software issue described in the source text. The issue was corrected in the modification to the MXTTOUT controller parameter settings. The affected devices were distributed nationwide to Alaska, Ohio, Texas, Georgia, and Michigan. Specific serial numbers affected include RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, and RO14035.
The source text does not specify instructions for consumers or healthcare providers on how to handle the recalled devices, nor does it report any injuries or illnesses associated with the use of these devices.
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.
- 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 (7)
- Serial #'s: RO10009
- RO10011
- RO10014
- RO13023
- RO13027
- RO14031
- RO14033 and RO14035
Distribution
Related recalls
Same manufacturer · Zimmer Biomet, Inc.
See all →- HighZimmer Biomet Recalls Spinal Rod Cutters Due to Fracture Risk
FDA (Devices) · 2020-12-30
- ModerateZimmer Biomet Recalls Polaris Spinal System Screws for Labeling Update
FDA (Devices) · 2020-12-23
- HighZimmer Biomet Recalls Hip Prosthesis Cups Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Components Due to Sterilant Biocompatibility Concerns
FDA (Devices) · 2020-11-11
- HighZimmer Biomet Recalls Hip Prosthesis Component Due to Sterilant Concerns
FDA (Devices) · 2020-11-11
Same hazard · software error
See all →- HighQuantum Rehab R-TRAK Powered Wheelchair Controller Recalled Due to Software Issue
FDA (Devices) · 2026-08-12
- HighDASH Rapid PCR Instrument Recalled Due to Software Issue Causing False Co-infection Results
FDA (Devices) · 2026-08-12
- HighQuantum Outback Powered Wheelchair Controller Recalled Due to Unexpected Braking Risk
FDA (Devices) · 2026-08-12
- HighREMISOL Advance Software Version 2.5 Recalled for Incorrect Test Result Reporting
FDA (Devices) · 2026-08-12
- HighQuantum Rehab Q6 Edge 3 Powered Wheelchair Controller Recalled for Unexpected Braking
FDA (Devices) · 2026-08-12