ROSA Surgical Device 2.5.8 recall: Software Issue
ROSA Surgical Device 2.5.8
Why was ROSA Surgical Device 2.5.8 recalled?
Potential for software to change the final tool orientation for the command position without command.
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. RO15050, RO15044, RO15048, RO15067, RO15045, RO15061, RO14041, RO14038, RO14039, RO14043, RO15051, RO15069, RO10011, RO14037, RO10014, RO15054, RO14035, RO15060, RO15063, RO14033, RO15059, RO15064, RO14031, RO14040, RO10009, RO13023, RO15053, RO15052, RO15058, RO13027, RO15046, and RO15062
- Product
- ROSA Surgical Device 2.5.8
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 64 units
- Distribution
- AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom
- Recall date
- November 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)