restor3d recalls Kinos Axiom Total Ankle Systems with incorrect patient-specific cutting guides that may cause delayed surgery, poor implant alignment, or revision surgery. Affected units have specific serial numbers and reference codes.
Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.
“restor3d Kinos Axiom Ankle Implant Recall: Incorrect Cutting Guides Risk Surgery.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/1134695-restor3d-kinos-axiom-ankle-implant-recall-incorrect-cutting-guides-risk. Based on FDA recall #Z-3178-2026 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3178-2026%22&limit=1).
The FDA announced on July 27, 2026, that restor3d Inc. is recalling the Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006 due to incorrect patient-specific cutting guides. The hazard includes potential implant loosening or the need for revision surgery.
How to tell if you have it
Brand: restor3d
Product: Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide)
REF: 5831-9006
Lot: D-788
UDI-DI: 00840097509945
Serial Numbers: 18169, 18059
Distribution: US Nationwide in FL, CO
The hazard
According to the FDA, ankle implantation systems were packaged with incorrect patient-specific cutting guides. This error may result in delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening/migration, or need for revision surgery.
Context
GovInfoNow's records show restor3d Inc. has two other recalls on record since March 30, 2022. On June 30, 2026, restor3d issued a recall for the Veritas Standard Glenoid Baseplate due to improper screw engagement risk. Other recent recalls of similar products include the Tornier Perip Screw Recall (Dec. 19, 2025) and the Zimmer Off-Axis Alliance Glenoid Reamer Guide Recalls (May 20, 2026).
How to tell if you have this one
Check for the system serial numbers 18169 or 18059. The product reference code is 5831-9006 with lot number D-788 and UDI-DI 00840097509945.
Brand
restor3d
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check System Serial Numbers
Look for serial numbers 18169 or 18059 on the product packaging or documentation.
Where it went and when
Where it was distributed
Distributed nationwide; the notice names 2 states.
Named in the notice
Covered by “nationwide”
Not listed
FDA distribution: “US Nationwide distribution in the states of FL, CO.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Named in the notice: Colorado, Florida.
Recall timeline
FDA published this recall 58 days after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4Added to GovInfoNow
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-3178-2026 (July 27, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-3178-2026 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.