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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Lantern Knee System Drill Plates Recalled for Incorrect Bone Cut Depth

Agency Publication Date: March 24, 2026
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Summary

Orthalign, Inc. is recalling 14 units of its Drill Plates used in the Lantern Knee System because they were manufactured out of specification. This manufacturing defect can lead to bone cuts being more than 0.11 inches (2.8448mm) deeper than intended during surgery. These components are used specifically during orthopedic knee procedures and were distributed exclusively in Utah.

Risk

If used during surgery, these drill plates can cause an excessive bone cut, potentially leading to improper implant fit, loss of structural bone integrity, or the need for corrective surgical intervention.

What You Should Do

  1. Stop using the recalled Lantern Knee System drill plates immediately.
  2. Identify affected units by checking the REF and Lot numbers on the product labeling: Size 1-5 (REF 402566, Lot 25091103BB) or Size 6-7 (REF 402567, Lot 25092204BB).
  3. Contact Orthalign, Inc. or your distributor to arrange for the return, replacement, or correction of the affected surgical components.
  4. Call the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls for additional information regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action
How to: Stop using the recalled device. Contact the manufacturer or your distributor to arrange return, replacement, or correction.

Affected Products

Product: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 1 -5 (component Lantern Knee System)
Variants: Size 1-5
Model / REF:
402566
Lot Numbers:
25091103BB
UDI:
00810832032427

Recall #: Z-1629-2026

Product: Drill Plate, Ortho Dev. Trimax - Pegged, PREF Size 6-7 (component Lantern Knee System)
Variants: Size 6-7
Model / REF:
402567
Lot Numbers:
25092204BB
UDI:
00810832032434

Recall #: Z-1630-2026

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 98516
Status: Active
Manufacturer: Orthalign, Inc
Sold By: Hospital systems; Surgical centers
Manufactured In: United States
Units Affected: 2 products (7 units)
Distributed To: Utah

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.