FDA Enforcement
Class II
Ongoing
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Recall: Z-1630-2026
·
Reported April 1, 2026
Enforcement
- Recall Number
- Z-1630-2026
- Event ID
- 98516
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Orthalign, Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- April 1, 2026
- Initiation Date
- February 10, 2026
- Classification Date
- March 24, 2026
- Address
- 120 Columbia Ste 500, Aliso Viejo, CA, 92656-4107, United States
Description
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)
Code Info
Lot # 25092204BB/ UDI:00810832032434
Distribution
US Nationwide distribution in the state of UT.
Quantity
7 units