Orthalign Lantern Knee System Drill Plate Recall - Class II
Summary
FDA issued a Class II medical device recall for Orthalign Inc.'s Lantern Knee System Drill Plates (REF 402567, Pegged, PREF Size 6-7). The recall was initiated because drill plates manufactured out of specification can result in bone cuts exceeding 00800" (2.8448mm), posing a risk of surgical complications. The affected devices were distributed nationwide with confirmed distribution in Utah.
What changed
FDA initiated Class II recall Z-1630-2026 for Orthalign Lantern Knee System Drill Plates manufactured out of specification. The defect creates a risk that bone cuts will exceed the intended 00800" (2.8448mm) dimension, potentially causing surgical complications or patient harm.
Hospitals, orthopedic surgeons, and healthcare facilities using the Lantern Knee System must immediately identify affected device lots, remove them from surgical use, and return or discard per Orthalign instructions. Continued use of non-conforming drill plates during knee replacement procedures may result in improper bone preparation, misalignment, or intraoperative complications requiring corrective intervention.
What to do next
- Identify and quarantine all affected Lantern Knee System Drill Plates (REF 402567, Pegged, PREF Size 6-7)
- Cease use of out-of-specification drill plates in surgical procedures immediately
- Report any adverse events related to this device to FDA MedWatch
Archived snapshot
Apr 9, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Orthalign, Inc
Device Recalls (Class II)
← All Device Recalls (Class II) Class II Z-1630-2026 · 20260401 · Ongoing
Product
Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 REF:402567 component Lantern Knee System
Reason for Recall
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
Distribution
US Nationwide distribution in the state of UT.
Source: openFDA Enforcement API
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