Class II — restor3d Inc.
| Recalling firm | restor3d, inc. |
|---|---|
| Registered facility | restor3d, inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| 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. |
| Product | Kinos Axiom Total Ankle System with Axiom PSR, Flat-cut (Cut Guide), REF: 5831-9006 |
| Quantity | 2 |
| Distribution | US Nationwide distribution in the states of FL, CO. |
| Initiated | 2026-07-27 |
| Classified | 2026-09-16 |
| Recall number | Z-3178-2026 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — restor3d Inc. (Z-3178-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/99512/
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