XTANT Medical Cervical Implants Have Incorrect Titanium Grade Label
XTANT Medical recalls cervical implants with incorrect titanium grade labels. Check product codes for CP Ti Grade 1-25 to avoid potential misidentification.
Lower-risk recall
Cervical Implants contain a label that incorrectly identifies the grade of titanium used.
Contact the company
What happened, in plain English
XTANT Medical is recalling cervical implants that have labels incorrectly identifying the grade of titanium used. This could lead to improper medical use if the wrong grade is assumed. Read more at govinfonow.com/recall/64132-xtant-medical-cervical-implants-have-incorrect-titanium-grade-label.
Source Summary by GovInfoNow · govinfonow.com/recall/64132-xtant-medical-cervical-implants-have-incorrect-titanium-grade-label · Updated August 19, 2026 · FDA enforcement record: FDA #Z-0429-2021
Cite this page
“XTANT Medical Cervical Implants Have Incorrect Titanium Grade Label.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/64132-xtant-medical-cervical-implants-have-incorrect-titanium-grade-label. Based on FDA recall #Z-0429-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0429-2021%22&limit=1).
Why it’s dangerous
The implants contain labels that incorrectly state the titanium grade. This could lead to using the wrong grade of titanium in medical procedures, potentially causing improper healing or complications.
Who’s affected
Patients who received these cervical implants from XTANT Medical are likely affected. Medical professionals using these implants for procedures are at risk of misidentification.
How to tell if you have this one
Check the label for reference numbers like X098-0106-STR to X098-0312-STR. The product includes specific DI numbers and expiration dates listed in the recall notice.
- Brand
XTANT Medical- Category
Medical device
What to do — step by step
Check Label Details
Look for reference numbers on the label, such as X098-0106-STR to X098-0312-STR, and verify the titanium grade listed.
Where it went and when
Where it was distributed
Distributed in 5 states.
FDA distribution: “US: FL, TX, CA, OH, AZ, OH OUS: None” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Florida, Ohio, Texas.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
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-0429-2021 (September 30, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-0429-2021 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.