Recall Z-3178-2026— restor3d Inc.
Class II · Ongoing
Class II FDA medical device recall by restor3d Inc., initiated 2026-07-27. It names one FDA 510(k) clearance: K223326. 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..
- Recalling firm
- restor3d Inc.
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-07-27
- Firm location
- Durham, NC, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.