ROSA Surgical Device 2.5.8 ROSA Surgical Device is a recall: Software Issue
ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for…
Why was ROSA Surgical Device 2.5.8 ROSA Surgical Device is a recalled?
The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
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: RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033 and RO14035
- Product
- ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 29 (8 US and 21 OUS)
- Distribution
- Nationwide Distribution to AK, OH, TX, GA, and MI
- Recall date
- December 6, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)