Drill Plate — Class II medical device recall Z-1629-2026
Ongoing recall by Orthalign, Inc, reported 2026-04-01, distributed nationwide. Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
| Recall number | Z-1629-2026 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Orthalign, Inc, Aliso Viejo, CA, United States |
| Recall initiated | 2026-02-10 |
| Classified | 2026-03-24 |
| Reported by FDA | 2026-04-01 |
| Distributed | Nationwide (US) |
| Quantity | 7 units |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00810832032427 |
| Lot numbers | 25091103BB |
| Model numbers | 402566 |
Product
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Reason for recall
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1629-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.