Zimmer Biomet Recalls ROSA Brain Surgical Navigation Systems
Zimmer Biomet is recalling 20 ROSA Brain surgical navigation systems because the head holder connector may lock up mechanically when tightened.
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 3/5 (High).
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, and the mechanical defect in a neurosurgical device presents a risk of harm during surgery, even though no specific injuries are reported in the source text.
Plain-English summary
Zimmer Biomet, Inc. is recalling 20 units of the ROSA Brain, 3.0.0 surgical navigation system. The device is intended for the spatial positioning and orientation of instrument holders or tool guides used by neurosurgeons to guide standard neurosurgical instruments. The recall is being conducted due to a complaint that the head holder connector locks up mechanically when tightened.
The affected units are distributed worldwide, including in the United States (California, Florida, Massachusetts, Minnesota, North Carolina, New York, Ohio, Pennsylvania, and Washington, D.C.) and in Australia and France. The specific serial numbers for the 20 units are BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, and BR16024.
Healthcare facilities and users should contact Zimmer Biomet, Inc. for instructions on how to address the mechanical locking issue with the head holder connector.
The recalled product
- Product
- ROSA Brain, 3.0.0 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 is…
- 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 (17)
- Device Listing No. D264591
- Serial No. BR16004
- BR16005
- BR16006
- BR16009
- BR16010
- BR16011
- BR16012
- BR16013
- BR16014
- BR16015
- BR16016
- BR16017
- BR16018
- BR16021
- BR16023
- BR16024.
Distribution
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