Quick Facts at a Glance
- Recall Date
- February 10, 2026
- Hazard Level
- HIGH
- Brand
- Orthalign
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 1 states
- At-Risk Groups
- GENERAL
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Medical Devices; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Orthalign
- Product type
- Orthopedic Drill Plate
- Model numbers
- Lot # 25092204BB/ UDI:00810832032434
- Sizes
- Size 6-7, PREF Size 6-7
- Sold at
- Unknown
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
February 10, 2026
Reported by FDA DEVICE
April 1, 2026
RecallRadar source check
April 8, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Drill plates manufactured out of specification can result in a bone cut in excess 00800"(2.8448mm)
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Orthalign, Inc or your healthcare provider for instructions. Notification method: Letter
About This Product
The Drill Plate is an orthopedic instrument used during knee surgery as part of the Lantern Knee System. The pegged design is intended to fit Pref Size 6-7 components during surgical procedures.
Why This Is Dangerous
Parts manufactured out of specification can lead to a larger-than-intended bone cut, which may necessitate additional surgery or medical intervention.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
Direct risk to surgical accuracy. Potential need for follow-up medical evaluation and possible extended recovery.
Practical Guidance
How to identify if yours is affected
- Verify Lot number on the device: Lot # 25092204BB
- Cross-reference with REF 402567 and product label 6-7 Pegged PREF size
Where to find product info
Device labeling, recall letter, and FDA enforcement page linked in notice
What timeline to expect
Recall notice provides no specific refund/replacement timeline; follow manufacturer instructions
If the manufacturer is unresponsive
- Document all communications
- File a consumer complaint with FDA if manufacturer is non-responsive
- Consider reporting to CPSC if appropriate
How to prevent similar issues
- Verify lot numbers on orthopedic implants before use
- Follow surgeons' and manufacturers' recall communications
- Ask suppliers for up-to-date product recalls before use
- Ensure proper device verification procedures during surgeries
Documentation advice
Keep recall notice, letter, and any correspondence with Orthalign and healthcare providers. Photograph serial labels and store packaging for records.
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Product Details
Brand: Orthalign Product: Drill Plate, Ortho Dev Trimax - Pegged, PREF Size 6-7 Reference: REF 402567 Lot/UDI: Lot # 25092204BB / UDI: 00810832032434 Sold in: United States, Utah distribution When sold: Unknown Price: Unknown Quantity: 7 units Recall date: 2026-02-10 Status: Active
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Pegged PREF Size 6-7
- Lantern Knee System component
- Out-of-spec drill plates can cause bone cuts up to 2.8448 mm
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Safety Guide
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