Rosa Spine 1.0.2 Stereotaxic Instrument recall: Software Issue
Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of…
Why was Rosa Spine 1.0.2 Stereotaxic Instrument recalled?
A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
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; SP14003 and SP14005
- Product
- Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of…
- Recalling firm
- Zimmer Biomet, Inc.
- Quantity
- 2
- Distribution
- Worldwide Distribution including France and Germany
- Recall date
- December 6, 2017
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)