Summary
The FDA issued a Class II for X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System. by XTANT Medical. Reason: The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with.
Details
Source
Device Recall
External ID
Z-0533-2022
Action Date
2022-02-09
Status
Terminated
Category
device
Product Description
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
Lot/Code Info: X060-0270, 8mm Titanium Insert, Axle System UDI (Primary DI Number): M697X06002701/$$7058963W Lot Number: 058963
Quantity Affected: 24 devices
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.
Distribution
U.S.: CA, MI, NV, and TX O.U.S.: Portugal
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-29
Company
Belgrade, MT
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 95 device recalls issued in the same week, part of 403 device-related FDA actions this month.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (XTANT Medical) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does XTANT Medical have FDA actions?
This is the only FDA action we have on record for XTANT Medical in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-0533-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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