ROSA Brain 3.0.0 Usage: The device is intended for the recall: Software Issue
ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by…
Why was ROSA Brain 3.0.0 Usage: The device is intended for the recalled?
Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
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 #'s: BR16004, BR16005, BR16006, BR16009, BR16010, BR16011, BR16012, BR16013, BR16014, BR16015, BR16016, BR16017, BR16018, and BR16021
- Product
- ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 18 (14 US and 4 OUS)
- Distribution
- Worldwide Distribution - US Nationwide in the states of OH, FL, MA, MN, DC, NC, CA, NY, PA and countries of Australia and France
- Recall date
- November 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)