X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Reported: February 9, 2022 Initiated: December 29, 2021 #Z-0533-2022
Product Description
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Reason for Recall
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Details
- Recalling Firm
- XTANT Medical
- Units Affected
- 24 devices
- Distribution
- U.S.: CA, MI, NV, and TX O.U.S.: Portugal
- Location
- Belgrade, MT
Frequently Asked Questions
What product was recalled? ▼
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.. Recalled by XTANT Medical. Units affected: 24 devices.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 9, 2022. Severity: Moderate. Recall number: Z-0533-2022.
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