restor3d recall: Kinos Axiom Total Ankle System with Axiom PSR
restor3d Inc. is recalling Kinos Axiom Total Ankle System with Axiom PSR – 2. The U.S. Food and Drug Administration published the recall on September 23, 2026; it began on July 27, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | Kinos Axiom Total Ankle System with Axiom PSR |
| Brand | restor3d |
| Company | restor3d Inc. |
| Type | Medical devices |
| Classification | Class II |
| Recall date | July 27, 2026 |
| Published by FDA | September 23, 2026 |
| Quantity | 2 |
| Recall ID | 99512 |
Recalled products
- Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
- FDA recall number
- Z-3178-2026
- Codes, lots and dates
- System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
- Quantity
- 2
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99512
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Durham, NC, United States
Why it was recalled
The reason the FDA lists: “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.”
Where it was sold
Nationwide. Distribution as the FDA records it: “US Nationwide distribution in the states of FL, CO.”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99512, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other restor3d recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Aug 26, 2026 |  restor3d recall: Veritas Standard Glenoid BaseplateMedical devices · 59 | Due to incorrect machining of peripheral screw hole resulting in potential for improper en… Serious | FDA Class II |
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| Oct 7, 2026 | Karl Storz Endoscopy recall: HOPKINS Telescope 30¿Medical devices · 6 eyepieces | Due to incorrect inside packaging label for eyepiece. Serious | FDA Class II |
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| Oct 7, 2026 | Siemens Healthcare Diagnostics recall: Atellica CH Revised C-Reactive ProteinMedical devices · 42940 units (3938 US, 39002 OUS) | The potential for falsely elevated results. Serious | FDA Class II |
| Oct 7, 2026 | Tandem Diabetes Care recall: T:slim Mobile ApplicationMedical devices · 177 | A beta (early-release) version of the iOS application, version 2.13 (TestFlight) had a sof… Serious | FDA Class II |
About this recall
Is restor3d Kinos Axiom Total Ankle System with Axiom PSR recalled?
Yes. restor3d Inc. recalled it on July 27, 2026; FDA published it September 23, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it 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.
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.