FDA Medical devices recall ·
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide) recall
- Recall number
- Z-3178-2026
- Date
- (initiated July 27, 2026)
- Company / brand
- restor3d Inc.
4001 E Nc 54 Hwy, Durham, NC, United States - Category
- Medical devices › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 2
- Hazard tags
- Laceration
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Why was it recalled?
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 should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
Distribution
US Nationwide distribution in the states of FL, CO.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (medical devices), recall Z-3178-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.