restor3d Inc.: Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

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.

Details
Distribution: US Nationwide distribution in the states of FL, CO.. Recall #Z-3178-2026, initiated 20260727. Voluntary: Firm initiated.

Products affected
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006

Recall status
Ongoing