Class II — Orthalign, Inc
| Recalling firm | OrthAlign, Inc |
|---|---|
| Registered facility | OrthAlign, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Ongoing |
| Reason | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) |
| Product | Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System |
| Quantity | 7 units |
| Distribution | US Nationwide distribution in the state of UT. |
| Initiated | 2026-02-10 |
| Classified | 2026-03-24 |
| Recall number | Z-1629-2026 |
| 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 — Orthalign, Inc (Z-1629-2026).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/98516/
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