Zimmer Biomet Recalls 16 MEDTECH ROSA Brain 3.0 Neurosurgical Devices
Zimmer Biomet is recalling 16 MEDTECH ROSA Brain 3.0 neurosurgical devices due to an unapproved change made by the supplier.
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 indicates a situation where use of the product may cause temporary or medically reversible health consequences. The source text does not report any specific injuries, illnesses, or fatalities, and the hazard is described as an unapproved change by the supplier rather than a direct, immediate physical danger like fire or shock.
Plain-English summary
Zimmer Biomet, Inc. is recalling 16 units of the MEDTECH ROSA Brain 3.0 device. This medical device is intended for the spatial positioning and orientation of instrument holders or tool guides used by neurosurgeons to guide standard neurosurgical instruments, such as biopsy needles, stimulation or recording electrodes, and endoscopes. The device is indicated for any neurological procedure in which the use of stereotactic surgery may be appropriate.
The recall was initiated because an unapproved change was made by the supplier. The affected units are identified by the following serial numbers: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, BR16021, BR16023, and BR16025.
The devices were distributed nationwide to California, Florida, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, Pennsylvania, and the District of Columbia. Healthcare facilities and users should stop using the affected devices and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- MEDTECH ROSA Brain 3.0 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 in
- Manufacturer
- Zimmer Biomet, Inc.
- Hazard
- Affected units
- 16
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 (15)
- Serial #'s: BR16004
- BR16005
- BR16006
- BR16009
- BR16010
- BR16011
- BR16012
- BR16013
- BR16014
- BR16015
- BR16016
- BR16017
- BR16018
- BR16021
- BR16023 and BR16025.
Distribution
Part of a larger recall action
This product is one of 2 recalled by Zimmer Biomet, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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