Zimmer Biomet ROSA Brain 3.0.0 Software Recall for Communication Errors
Zimmer Biomet is recalling 18 units of ROSA Brain 3.0.0 software due to communication errors between software components and the controller.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for medical devices with potential for serious injury.
Plain-English summary
Zimmer Biomet, Inc. is recalling 18 units of ROSA Brain 3.0.0 software. The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The recall is due to communication errors between ROSANNA BRAIN software, MARIO software, and the Staubli CS8C controller.
The affected units were distributed worldwide, including in the United States (Ohio, Florida, Massachusetts, Minnesota, District of Columbia, North Carolina, California, New York, and Pennsylvania) and in Australia and France. The specific serial numbers affected are BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, and BR16021.
Healthcare facilities and users should contact Zimmer Biomet for instructions on how to address the communication errors and ensure the safe use of the device.
The recalled product
- Product
- ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device…
- Manufacturer
- Zimmer Biomet, Inc.
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 (14)
- Serial #'s: BR16004
- BR16005
- BR16006
- BR16009
- BR16010
- BR16011
- BR16012
- BR16013
- BR16014
- BR16015
- BR16016
- BR16017
- BR16018
- and BR16021
Distribution
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