restor3d Kinos Axiom Total Ankle System with Axiom PSR, Flat-Cut (Cut Guide)
The Kinos Axiom Total Ankle System was packaged with incorrect cutting guides, which may cause delayed surgery, poor alignment, or need for revision.
Moderate risk
Using it may cause temporary or medically reversible health problems. Serious harm is unlikely.
FDA Class II recall · How risk is rated
What happened
restor3d Inc., of Durham, North Carolina, began a recall on July 27, 2026, of the Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006, because ankle implantation systems were packaged with incorrect patient-specific cutting guides.
The incorrect guides may result in delayed surgery, the need to use standard instrumentation, reduced fixation or poor alignment of implants, implant loosening or migration, or need for revision surgery. The product was distributed nationwide in the states of Florida and Colorado, and the recall was added to the FDA's Enforcement Report on September 16, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medical device recalls:
- A device recall doesn't always mean you must stop using it: it may need to be checked, adjusted or fixed.
- Talk to your health care provider before you stop using it.
Is yours affected?
Match the UDI-DI, lot code and reference number listed under your product.
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide)
- UDI-DI
- 00840097509945
- Reference number
- 5831-9006
- Lot
- D-788
Details
- Company began the recall
- Event ID
- 99512
- Recall No.
- Z-3178-2026
- Company
- restor3d Inc.Durham, North Carolina
- Hazard
- Device defect
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
