Lantern Surgical Assistant (HSA) 405204Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00810832031451), received between Jul 9, 2024 and Nov 18, 2025 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Communication or Transmission Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K200892); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 18, 2025Off-Label Use; Communication or Transmission Problem; Off-Label Use; Communication or Transmission Problem

  THE REFERENCE SENSOR WOULD NOT CONNECT TO THE LANTERN UNIT. THEY TRIED OPENING A NEW UNIT AND USING IT WITH A NEW BATTERY / OLD BATTERY / ETC. TWO TO THREE YELLOW FLASHES FOLLOWED BY A STEADY YELLOW LIGHT. A DEMO REFERENCE SENSOR WAS USED ON THE PATIENT AND IT FAILED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23585490 ↗
• InjuryAug 26, 2025Incorrect Measurement; Incorrect Measurement

  THE LANTERN UNIT'S ACCURACY WAS CALLED INTO QUESTION FOR THE FEMORAL CUT. THE SURGEON CORRECTED INTRA-OPERATIVELY.

  Patient problems: Joint Laxity

  MAUDE report 22895835 ↗
• MalfunctionJul 9, 2024Output Problem; Output Problem

  TIBIA MEASUREMENTS LOOKED GREAT, BUT WAS UNABLE TO GET FLEXION NUMBERS FOR THE FEMUR. CASE WAS COMPLETED USING THE ORTHALIGN REFERENCE SENSOR FOR THE TIBIA AND STANDARD INSTRUMENTATION FOR THE FEMUR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19702853 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K200892. One submission often covers many models, so check the product and lot details in each record.

• Z-1630-2026 · Feb 10, 2026 · Open, Classified
  Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
• Z-1629-2026 · Feb 10, 2026 · Open, Classified
  Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System