Orthalign Drill Plate for Lantern Knee System recalled for oversized bone cuts
Orthalign's Trimax Drill Plate (Size 6-7, REF 402567) in some units may cut bone larger than intended during knee surgery. The defect affects 7 units distributed in Utah. No injuries have been reported.
From the FDA notice · Read the official notice ↗
What to do
- If you received Lantern Knee System drill plates with lot number 25092204BB or UDI 00810832032434, do not use them
- Contact Orthalign or your supplier for instructions on replacement or return
- Review your inventory records to identify affected units
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
- Sold in
- Nationwide
- Made for
- Adults (0 months and older)
This recall covers 2 products — see all of them.
Details
- Units affected
- 7 units
- Illnesses reported
- None reported
- Manufactured in
- 120 Columbia Ste 500, Aliso Viejo, CA, United States
- Classification
- Class II
- Recall number
- Z-1630-2026
In the FDA's words
- Description
- Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) Lot # 25092204BB/ UDI:00810832032434 Distribution: US Nationwide distribution in the state of UT. Affected quantity: 7 units
- Hazard
- Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
2 products in this recall
The agency lists each product separately. Check every one you might have.
- Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee SystemZ-1629-2026 · 7 units
- Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System (this page)Z-1630-2026 · 7 units