Device recall
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
- Recall number
- Z-3178-2026
- Event id
- 99512
- Status
- Ongoing
- FDA classification
- Class II
- Recalling firm
- restor3d Inc.
- Report date
- Sep 23, 2026
- Posted
- Sep 16, 2026
- Initiated
- Jul 27, 2026
- Center classification date
- Sep 16, 2026
- Product code
- OYK
- Device type
- Ankle Arthroplasty Implantation System
- 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
- Quantity
- 2
- Code info
- System Serial Numbers: 18169, 18059. REF: 5831-9006, Lot: D-788, UDI-DI: 00840097509945.
- Distribution
- US Nationwide distribution in the states of FL, CO.
- Voluntary or mandated
- Voluntary: Firm initiated
- Related 510(k)s
- K223326
- Location
- Durham, NC, United States