FDA-Device2026-04-01Class IIPROCESSING DEFECT
Orthalign Drill Plate for Lantern Knee System recalled for oversized bone cuts
OTHERNationwide distribution
Stop using Orthalign Drill Plate component
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.
- 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
Hazard
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
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 1 -5 REF:402566 component Lantern Knee System
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1629-2026More Orthalign, Inc recalls
- FDA-Device2026-04-01Orthalign Drill Plate for Lantern Knee System recalled for oversized bone cuts
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