⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

Medical DevicesSource: FDA (device) · Date: 2026-09-23

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
restor3d Inc.
Product
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of FL, CO.
Recall initiated
2026-07-27
Code info
System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
Product quantity
2
Voluntary mandated
Voluntary: Firm initiated
City
Durham
State
NC
Country
United States
Event id
99512
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