Drill Plate recall (Orthalign, Inc)
Medical deviceClass IIOngoing
Summary: Orthalign, Inc is recalling Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System. Reason: Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm).
What is being recalled
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Why
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
US Nationwide distribution in the state of UT. (states named: Utah)
How to tell if yours is affected
Lot # 25091103BB/ UDI: 00810832032427
What to do
Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.
Recall facts
| Recall number | Z-1629-2026 |
| Category | Medical device |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | February 10, 2026 |
| Reported | April 1, 2026 |
| Company | Orthalign, Inc |
| Company location | Aliso Viejo, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 7 units |
More recalls from Orthalign, Inc · all medical device recalls · recalls from February 2026