FDA Device recall Z-3178-2026
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
- FDA Device
- Class II
- ongoing
- Published 2026-09-23
On 2026-09-23 the FDA classified a Class II recall of Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006 by Restor3d, citing ankle implantation systems were packaged with incorrect patient-specific cutting guides, which may result in: delayed surgery, the need to use standard instrumentation, reduced fi….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-3178-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-07-27 |
| Published | 2026-09-23 |
| Last updated | 2026-09-29 05:30 UTC |
| Company | Restor3d |
| Distribution | US |
Product
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Reason
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.
Identifiers
| code_info | System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-29 05:30 UTC. Current status: ongoing.
Other recalls by Restor3d
- Brand Name: Veritas Standard Reverse Total Shoulder Product Name: Veritas Standard Glenoid Baseplate Model/Catalog Number: 1500-1030
FDA Device · Class II · 2026-08-26 · Restor3d - Non-Sterile Double Ended Trial Kit, Small Footprint, (6110-N01-KTS01) for the Cervical Cage
FDA Device · Class II · 2022-05-11 · Restor3d - Evans Wedge Disposable Trials, Medium Footprint, 10mm Thickness (6101-20181018)
FDA Device · Class II · 2022-05-11 · Restor3d - Evans Wedge Disposable Trials, Large Footprint, 8mm Thickness (Model: 6101-22200818)
FDA Device · Class II · 2022-05-11 · Restor3d
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-3178-2026%22
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