Spinal Fusion Implant Insert Recalled for Assembly Defect
XTANT Medical is recalling 24 units of the X060-0270 8mm Titanium Insert for the Axle Interspinous Fusion System due to a manufacturing defect that prevents proper assembly of crossbar plates. The defect could affect the device's function during spinal fusion procedures.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a spinal implant with a manufacturing defect that affects proper assembly and function. While no illnesses or injuries have been reported, this is a risk-of-harm product where improper assembly could lead to device malfunction during implantation.
Plain-English summary
XTANT Medical is recalling 24 units of the X060-0270 8mm Titanium Insert used in the Axle Interspinous Fusion System. The recall is due to a manufacturing defect in which the proximal opening of the inserts is out of specification. This defect prevents the crossbar plates from appropriately engaging with the insert, which could compromise the device's ability to function as intended during use.
The affected devices were distributed in the United States (California, Michigan, Nevada, and Texas) and Portugal. The recalled lot number is 058963.
Healthcare providers who received devices from this lot should stop using them and contact XTANT Medical for replacement units or further instructions. Patients who have received this implant should contact their healthcare provider to discuss any concerns and determine appropriate next steps.
The recalled product
- Product
- X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
- Manufacturer
- XTANT Medical
- Category
- Medical Device — Spinal Implant
- Hazard
- assembly-defect
- improper-engagement
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- X060-0270
- 8mm Titanium Insert
- Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963
Distribution
Distributed in 4 states:
- CA
- MI
- NV
- TX
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