Lantern Surgical Assistant (LSA) 406000-02Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 00810832031567), received between Sep 2, 2022 and Nov 4, 2025 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (9 reports).

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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 4, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  WHEN TIBIA REGISTRATION WAS PERFORMED, IT WAS SET TO VARUS, BUT THERE WAS A SUSPICION OF VALGUS WHEN VISUALLY OBSERVED. WHEN THE ALIGNMENT WAS CHECKED MANUALLY, IT WAS CLEARLY VALGUS. TRIED TIBIAL REGISTRATION AGAIN, BUT THE SAME ISSUE OCCURRED. SURGERY WAS COMPLETED WITH KNEEALIGN. THE SURGERY WAS PERFORMED ON THE RIGHT LEG. THE COMPLAINT EVENT WAS FOUND BEFORE THE LANTERN SETTING AND THE RESECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23469650 ↗
• MalfunctionJul 8, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE UNIT PRODUCED WRONG NUMBERS ON DISTAL FEMUR CUT. THE SURGEON SET THE VALUES TO 4 DEGREES OF FLEXION AND 0 DEGREES V/V ON DISTAL FEMUR CUT, BUT AFTER HE REGISTERED, THE NUMBERS CHANGED TO 1 DEGREE EXTENSION AND 0.5 DEGREES VALGUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22438909 ↗
• MalfunctionMar 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  FEMUR REGISTRATOIN WAS COMPLETED BUT THE VALUES ON THE SUMMARY SCREEN ON THE NEXT PAGE DID NOT MATCH THE REGISTRATION VALUES. THE NUMBERS CHANGED WHEN ADVANCING TO THE REGISTRATION SCREEN. THE CASE WAS COMPLETED WITH MANUAL INSTRUMENTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21577034 ↗
• MalfunctionMar 11, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  FEMUR REGISTRATION WAS COMPLETED BUT THE VALUES ON THE SUMMARY SCREEN ON THE NEXT PAGE DID NOT MATCH THE REGISTRATION VALUES. THE NUMBERS CHANGED WHEN ADVANCING TO THE REGISTRATION SCREEN. THE CASE WAS COMPLETED WITH MANUAL INSTRUMENTATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21576541 ↗
• MalfunctionMar 5, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  NAVIGATION UNIT DISPLAYED 2.5 DEGRESS FLEXION ON FEMUR BUT THEN WHEN ADVANCED TO NEXT SCREEN IT SHOWED 1 DEGREE OF FLEXION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21525997 ↗
• MalfunctionMar 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SURGEON WAS HAVING DIFFICULTY WITH THE NAVIGATION READING TAS NEEDING LESS FLEXION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21507202 ↗
• MalfunctionDec 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  SURGEON WAS HAVING DIFFICULTY WITH THE NAVIGATION READING TAS NEEDING LESS FLEXION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21020969 ↗
• MalfunctionNov 5, 2024Expiration Date Error; Expiration Date Error

  AN EXPIRED NAVIGATION UNIT WAS USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20610786 ↗
• MalfunctionSep 23, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  AN EXPIRED UNIT WAS UNKNOWINGLY USED IN A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20279236 ↗
• MalfunctionAug 22, 2024Inadequate User Interface; Delayed Program or Algorithm Execution; Inadequate User Interface; Delayed Program or Algorithm Execution

  CUSTOMER REPORTED THAT THE NAVIGATION UNIT WOULD NOT CALIBRATE. UPON RECEIPT OF THE UNIT AND INVESTIGATION OF THE COMPLAINT, IT WAS FOUND THAT THE LOG SHOWS THAT BT CALIBRATION WAS SKIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20034289 ↗
• MalfunctionAug 16, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  DISTAL FEMUR WAS CALIBRATED AND REGISTERED WITHOUT INCIDENT OR CONCERN. DISTAL FEMORAL CUT WAS MADE AND PROGRESSED TO TIBIA WITHOUT INCIDENT. IT WAS OBSERVED THAT THE EXTENSION GAP WAS EXTREMELY TIGHT. AN ADDITION 4MM WAS RESECTED OFF THE TIBIA AND AN ADDITION 2MM OFF FEMUR. GUIDE PINS AND SPACER BLACK WERE OBSERVED TO BE DIVERGING INTO EACH OTHER.

  Patient problems: Joint Laxity

  MAUDE report 17560690 ↗
• MalfunctionFeb 20, 2023Incorrect Measurement; Incorrect Measurement

  POSSIBLE INACCURATE MEASUREMENT -- IT WAS REPORTED THAT THE USER (SURGEON) DID NOT TRUST THE DEGREES OF VARUS THE DEVICE WAS READING FOR THE DISTAL FEMUR. BELIEVED THAT THE NUMBERS SHOULD HAVE BEEN FOR THE OPPOSITE SIDE BUT THE UNIT WAS SET TO THE CORRECT SIDE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16402014 ↗
• MalfunctionSep 2, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT "THE 14 AND 14 AT THE BOTTOM ARE INCORRECT BASED ON THE 13 IN THE MIDDLE." NO PATIENT INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352771 ↗

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