FDA DevicesClass II
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component L...
Published: April 1, 2026Recall ID: Z-1629-2026Category: devicesCountry: US
Reason for Recall / Hazard
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Product Description & Identification
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Affected Products
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Additional Source Details
| Field | Value |
|---|---|
| City | Aliso Viejo |
| State | CA |
| Event id | 98516 |
| Address 1 | 120 Columbia Ste 500 |
| Code info | Lot # 25091103BB/ UDI: 00810832032427 |
| Postal code | 92656-4107 |
| Report date | 20260401 |
| Product type | Devices |
| Product quantity | 7 units |
| Reason for recall | Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260210 |
| Initial firm notification | Letter |
| Center classification date | 20260324 |
Overview
- Recalling FirmOrthalign, Inc
- StatusOngoing
- Risk LevelClass II
- DistributionUS Nationwide distribution in the state of UT.