Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Summary
The FDA issued a Class II for Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9 by restor3d Inc.. Reason: Ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standar.
Details
Source
Device Recall
External ID
Z-3178-2026
Action Date
2026-09-23
Status
Ongoing
Category
device
Product Description
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Lot/Code Info: System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
Quantity Affected: 2
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.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-07-27
Company
Durham, NC
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 203 device recalls issued in the same week, part of 445 device-related FDA actions this month.
restor3d Inc. has 10 FDA actions in our database, including 5 recalls and 5 clearances.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (restor3d Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does restor3d Inc. have FDA actions?
restor3d Inc. has 10 FDA actions in our database, including 5 recalls and 5 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "Z-3178-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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