Zimmer Biomet Recalls ROSA Brain 3.0 Neurosurgical Devices
Zimmer Biomet is recalling three ROSA Brain 3.0 neurosurgical devices due to insufficient washers in the telescopic arm that allow unwanted movement.
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 defect involves a mechanical failure (unwanted movement) in a device used during neurosurgery, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Zimmer Biomet, Inc. is recalling three units of the 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. The recall affects serial numbers BR16004, BR15002, and BR15003.
The recall was initiated because of an insufficient amount of washers in the Telescopic Arm of the device. This defect allows some movement of the device, which could compromise its intended function during neurosurgical procedures.
The affected units were distributed worldwide, including in the United States (District of Columbia) and internationally to Australia and France. Healthcare facilities and users should stop using the affected devices and contact Zimmer Biomet for further instructions on the recall.
The recalled product
- Product
- ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may…
- Manufacturer
- Zimmer Biomet, Inc.
- Affected units
- 3
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 (3)
- Serial No. BR16004
- BR15002
- and BR15003
Distribution
Distribution scope not specified by the agency.
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