FDA Device recall Z-1630-2026
Drill Plate, Ortho Dev
- FDA Device
- Class II
- ongoing
- Published 2026-04-01
On 2026-04-01 the FDA classified a Class II recall of Drill Plate, Ortho Dev by Orthalign, citing drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm).
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1630-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-02-10 |
| Published | 2026-04-01 |
| Last updated | 2026-09-13 11:58 UTC |
| Company | Orthalign |
| Distribution | US |
Product
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Reason
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Identifiers
| code_info | Lot # 25092204BB/ UDI:00810832032434 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:58 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1630-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.