FDA-Device2026-09-23Class IIPACKAGING DEFECT
Restor3d Kinos Axiom Total Ankle System recalled for incorrect cutting guides
What this means
Two Kinos Axiom Total Ankle System units were packaged with incorrect patient-specific cutting guides. Using the wrong guides during surgery could lead to poor implant alignment, loose implants, or the need for revision surgery.
- If you received a Kinos Axiom ankle implant system (Serial Numbers 18169 or 18059, Lot D-788), contact restor3d Inc. immediately before proceeding with surgery.
- Verify that your cutting guides match your patient-specific order before surgery.
- Contact your surgeon if you have already undergone surgery with this system and have concerns about implant stability or alignment.
The agency's original wording
Hazard
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of FL, CO.
Affected count
2
Manufactured in
4001 E Nc 54 Hwy, Suite 3160, Durham, NC, United States
Products
Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3178-2026Want us to check the next one for you?
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