FDAFDA recall Z-3178-2026 · Sep 23, 2026
restor3d Inc.: Kinos Axiom Total Ankle System with Axiom PSR recall
Recall found
Product
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Reason for recall
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.
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
- Quantity
- 2
- Distribution
- US Nationwide distribution in the states of FL, CO.
- Recalling firm
- restor3d Inc., Durham, NC
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-07-27
Source: openFDA enforcement record Z-3178-2026 · search recall number Z-3178-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.