ROSA Brain 3.0 Intended for the spatial positioning and recall
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…
Why was ROSA Brain 3.0 Intended for the spatial positioning and recalled?
Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Serial No. BR16004, BR15002, and BR15003
- 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…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 3 units
- Distribution
- Worldwide Distribution - US (DC) and Internationally to Australia and France.
- Recall date
- November 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)