Lantern Surgical Assistant (LSA) KA406000-02Recalls & reported problems
Orthalign, Inc. · Packaged Assembly, Nav Unit, LSA (JP) · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00810832031963), received between Dec 26, 2024 and Dec 26, 2024 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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.
Reports received per month
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 26, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
THE VALUES SHOWN BY THE NAVIGATION UNIT DO NOT MATCH THE ACTUAL VALUES MEASURED. THE EXTENSION GAP WAS CONFIRMED BY INSERTING A SPACER BLOCK 10 MM (ACTUAL MEASUREMENT 19 MM), AND THE GAP WAS MEASURED IN EXTENSION AND FLEXION WITH THE LANTERN. THE EXTENSION GAP VALUE (CENTER VALUE 7MM) AND FLEXION GAP VALUE (CENTER VALUE 18MM) WERE INDICATED. THE OPERATION WAS COMPLETED WITH CONVENTIONAL INSTRUMENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21021578 ↗
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, ClassifiedDrill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
- Z-1629-2026 · Feb 10, 2026 · Open, ClassifiedDrill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 REF:402566 component Lantern Knee System
Other Orthopedic Stereotaxic Instrument devices
- REAL INTELLIGENCE ROB10024Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall924 reports
- NA 209063Mako Surgical Corp. · Orthopedic stereotaxic instrument2 recalls602 reports
- RESTORIS, RIO 212760Mako Surgical Corp. · Orthopedic stereotaxic instrument605 reports
- REAL INTELLIGENCE ROB10013Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 recall528 reports
- VELYS 4515-70-105Depuy (Ireland) · Orthopedic stereotaxic instrument578 reports
- VELYS 4515-70-106Depuy (Ireland) · Orthopedic stereotaxic instrument564 reports
- NA 209999Mako Surgical Corp. · Orthopedic stereotaxic instrument522 reports
- Mazor X System TPL0059-06Mazor Robotics Ltd · Orthopedic Stereotaxic Instrument2 recalls2 deaths392 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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