FDAFDA · Food and drugs·Recall number Z-3178-2026
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Published September 23, 2026 · Recall initiated: July 27, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- restor3d Inc.
- Distributor
- US Nationwide distribution in the states of FL, CO.
- Lot
- System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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