FDA-Device2026-04-01Class IIPROCESSING DEFECT
Orthalign Drill Plate for Lantern Knee System recalled for oversized bone cuts
What this means
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.
- 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
The agency's original wording
Hazard
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the state of UT.
Affected count
7 units
Manufactured in
120 Columbia Ste 500, Aliso Viejo, CA, United States
Products
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1630-2026Want us to check the next one for you?
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