X060-0270 recall
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Why was X060-0270 recalled?
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
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?
X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963
- Product
- X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
- Recalling firm
- XTANT Medical
- Quantity
- 24 devices
- Distribution
- U.S.: CA, MI, NV, and TX O.U.S.: Portugal
- Recall date
- February 9, 2022
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)