Reported Sep 23, 2026 · Ongoing · Updated Sep 29, 2026
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
restor3d Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: restor3d Inc. · 4001 E Nc 54 Hwy · Durham, NC · 27709
Is this the product you have?
- Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide)
- REF5831-9006
- Lot codes and dates
- System Serial Numbers
1816918059
- REF5831-9006
- LotD-788
- UDI-DI00840097509945
- System Serial Numbers
- Amount recalled
- 2
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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