Class II
Medical Device Recall: Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
restor3d Inc. · July 27, 2026
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.
Distribution
US Nationwide distribution in the states of FL, CO.
States Affected
NATIONWIDE
Quantity Affected
2
Source: FDA (openFDA Device Enforcement)
Recall number: Z-3178-2026
Status: ongoing
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