ROSA Brain 3.0 Stereotaxic Instrument Recalled for Positioning Errors
Zimmer Biomet is recalling 16 ROSA Brain 3.0 Stereotaxic instruments because the robot arm may move to the wrong position during surgery.
What this means for you
Illness, injury, or structural failure has been reported. 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, and the hazard involves a surgical device moving to the wrong position, which presents a significant risk of injury to patients during neurosurgery.
Plain-English summary
Zimmer Biomet, Inc. is recalling 16 units of the ROSA Brain 3.0 Stereotaxic instrument. This computer-assisted surgical device is intended for the spatial positioning and orientation of instrument holders used by neurosurgeons.
The recall was initiated because the robot arm associated with the device may be sent to the wrong position. The affected units were distributed to California, the District of Columbia, Florida, Illinois, Kentucky, Massachusetts, Minnesota, North Carolina, New York, Ohio, and Pennsylvania.
The specific units involved are identified by the following codes: BR16005, BR16004, BR16006, BR16012, BR16011, BR16009, BR16010, BR16014, BR16013, BR16015, BR16021, BR16017, BR16018, BR16016, BR16023, and BR16025. Healthcare facilities and users should stop using these devices and contact the manufacturer for further instructions.
The recalled product
- Product
- ROSA Brain 3.0 Stereotaxic instrument Computer-assisted surgical device. Intended for the spatial positioning and orientation of instrument holders to be used by neurosurgeons.
- Manufacturer
- Zimmer Biomet, Inc.
- 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 (16)
- BR16005
- BR16004
- BR16006
- BR16012
- BR16011
- BR16009
- BR16010
- BR16014
- BR16013
- BR16015
- BR16021
- BR16017
- BR16018
- BR16016
- 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.
See all 2 products in this recall →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 · positioning error
See all →- SevereHitachi Proton Beam Therapy System Recall Over Positioning Software Issue
FDA (Devices) · 2026-03-04
- HighPatient positioning systems recalled over stereotactic radiosurgery tolerance errors
FDA (Devices) · 2026-01-21
- HighDORO Easy-Connect Navigation Adaptor compatibility issue recall
FDA (Devices) · 2025-06-04
- HighSpinal Fusion Device Recall: Setscrew Insertion and Tightening Issues
FDA (Devices) · 2024-05-15
- HighTruDi Navigation System position discrepancy during ENT surgery
FDA (Devices) · 2023-11-01