XTANT Medical recalls X060-0270 8mm Titanium Insert for misaligned plates that could prevent proper spinal fusion. Affected units have specific UDI and lot numbers. Contact for repair or replacement.
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
“XTANT Medical X060-0270 8mm Titanium Insert Recall: Misaligned Plates Risk Injury.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/61326-xtant-medical-x060-0270-8mm-titanium-insert-recall-misaligned-plates. Based on FDA recall #Z-0533-2022 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0533-2022%22&limit=1).
XTANT Medical voluntarily recalled X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System devices due to an out-of-specification proximal opening that prevents crossbar plate engagement, the FDA said on Dec. 29, 2021.
How to tell if you have it
Brand: XTANT Medical
Product: X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System
UDI (Primary DI Number): M697X06002701/$$7058963W
Lot Number: 058963
Quantity: 24 devices
The hazard
The proximal opening of the inserts exhibits an out-of-specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Context
GovInfoNow's records show XTANT Medical has two other recalls on record since May 12, 2020. Other recent recalls of similar products include XTANT Medical Irix-C Forceps Inserter Recall: Fractured Strike Plate Hazard (May 12, 2020), XTANT Medical Cervical Implants Have Incorrect Titanium Grade Label (Sept. 30, 2020), XTANT Medical Xpress Pedicle Screw System: Incorrect Labeling Risk (Feb. 18, 2026), Howmedica TRIATHLON Hinge Insert Recall: Oxidation Risk in Orthopedic Implants (July 30, 2026), and Encore Medical RSP Humeral Socket Insert Recall: Incorrect Labeling Hazard (Jan. 15, 2026).
How to tell if you have this one
Check for the UDI (Primary DI Number) M697X06002701 and lot number 058963 on the product. The product was sold with specific model numbers X060-0270 and 8mm Titanium Insert.
Brand
XTANT Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the UDI number M697X06002701 and lot number 058963 on the product packaging or label.
Where it went and when
Where it was distributed
Distributed in 4 states.
Listed by the agency
Not listed
FDA distribution: “U.S.: CA, MI, NV, and TX O.U.S.: Portugal” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: California, Michigan, Nevada, Texas.
Recall timeline
FDA terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
Official source: FDA Recall #Z-0533-2022 (December 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0533-2022 to see it in context.
Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.