Recall Z-3178-2026 ยท OYK Ankle Arthroplasty Implantation System
restor3d Inc.
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
| Date | Sep 16, 2026 (initiated Jul 27, 2026) |
| Status | Open, Classified |
| 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. |
| Root cause | Labeling Change Control |
| Action | 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 |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of FL, CO. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K223326 | Axiom PSR System Restor3D, Mar 30, 2023 |