Recall Z-1629-2026— Orthalign, Inc
Class II · Ongoing
Class II FDA medical device recall by Orthalign, Inc, initiated 2026-02-10. It names one FDA 510(k) clearance: K200892. Product: 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).
- Recalling firm
- Orthalign, Inc
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2026-02-10
- Firm location
- Aliso Viejo, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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)
Data sourced from openFDA. This site is unofficial and independent of the FDA.