ROSA Surgical Device 2.5.8. It is intended to be used recall: Software Issue
ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or…
Why was ROSA Surgical Device 2.5.8. It is intended to be used recalled?
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
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, and RO13023
- Product
- ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 21 (4 US and 17 OUS)
- Distribution
- OH, MI and TX
- Recall date
- November 22, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)