ROSA Surgical Device 2.5.8 recall
ROSA Surgical Device 2.5.8
Why was ROSA Surgical Device 2.5.8 recalled?
Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
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. RO10011, RO10014, RO13023 and RO13027
- Product
- ROSA Surgical Device 2.5.8
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 22 units (4 US and 18 OUS)
- Distribution
- AR, OH, MI, and TX
- Recall date
- December 6, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)