Lantern 402566Recalls & reported problems
Orthalign, Inc. · DRILL PLATE, ORTHO DEV. TRIMAX - PEGGED, P-REF SIZE 1 - 5 · Class 2
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 0
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 1
Summary
No MAUDE adverse event reports in our data reference this device identifier directly.
1 FDA recall record name this device's identifier, 1 still open.
1 other recall 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. How this data works · Data updated Oct 13, 2026.
Recalls naming this device
- Feb 10, 2026Open, Classified
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Z-1629-2026 · Root cause: Nonconforming Material/Component · FDA record ↗
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
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.