restor3d Inc. recalls Kinos Axiom Total Ankle System with Axiom PSR
- Recalling company
- restor3d Inc.
- Product
- Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
- Reason
- 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.
- Classification
- Class II – may cause temporary or medically reversible health consequences
- Recall date
- Jul 27, 2026
- Reported
- Sep 23, 2026
- Distribution
- US Nationwide distribution in the states of FL, CO.
- Status
- Ongoing
- Quantity
- 2
- Lot / codes
- System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
- Company location
- Durham, NC
- Recall type
- Voluntary: Firm initiated
- Recall number
- Z-3178-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number Z-3178-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.