Recall Z-3178-2026
restor3d Inc. · initiated July 27, 2026
Product
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Codes / lots: System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
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.
FDA-determined cause: Labeling Change Control
Action taken
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
Details
- Recall number
- Z-3178-2026
- Initiated
- July 27, 2026
- Posted by FDA
- September 16, 2026
- Product code
- OYK – Ankle Arthroplasty Implantation System
- Quantity
- 2
- Distribution
- US Nationwide distribution in the states of FL, CO.
- Recalling firm
- restor3d Inc., Durham, NC