Orthalign Drill Plate for Lantern Knee System recalled for oversized bone cuts
Orthalign drill plates (Trimax-Pegged, Sizes 1–5, REF 402566) in one lot may have been made outside specifications. This could cause bone cuts larger than intended during knee surgery. Seven units were distributed in Utah.
From the FDA notice · Read the official notice ↗
What to do
- Stop using drill plates from lot 25091103BB immediately
- Contact your surgical supplier or Orthalign for instructions on return or replacement
- If you have already used this component, consult your surgical team about patient follow-up
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 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-1629-2026
In the FDA's words
- Description
- Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm) Lot # 25091103BB/ UDI: 00810832032427 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 System (this page)Z-1629-2026 · 7 units
- Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee SystemZ-1630-2026 · 7 units