Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut… recallZ-3178-2026 · restor3d Inc. · initiated Jul 27, 2026
Class II Open, Classified All recalls posted in September 2026
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from restor3d Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
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.
FDA root cause category: Labeling Change Control
What the company is doing
On 7/28/2026, recall notices were emailed to customers who were asked to do the following: 1) Segregate and return affected devices. 2) Complete and return the response form. If additional questions, contact firm at 984-201-2310
Recall details
- Recall number
- Z-3178-2026
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Jul 27, 2026
- Posted by the FDA
- Sep 16, 2026
- Recalling firm
- restor3d Inc.
- Quantity
- 2
- Product code
- OYK
- FDA submissions
- K223326
- Distribution
- US Nationwide distribution in the states of FL, CO.
Product description
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Code information (models, lots, serial numbers)
System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- restor3d Kinos Axiom PSR 5831-9006Restor3d, Inc. · Ankle Arthroplasty Implantation System1 recall1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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