ROSA Surgical Device 2.5.8 recall
ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Why was ROSA Surgical Device 2.5.8 recalled?
Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
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?
Model No. 2.5.8., Serial No. RO10009, RO10011, RO10014, RO13023, RO13027, RO14031, RO14033, RO14035, and RO14037.
- Product
- ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 31 units
- Distribution
- US distribution in AR, GA, OH, MI, and TX.
- Recall date
- November 29, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)