Quick Facts at a Glance
- Recall Date
- February 10, 2026
- Hazard Level
- HIGH
- Brand
- Orthalign
- Category
- Health & Personal Care
- Sold At
- Multiple Retailers
- 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
- Pegged Drill Plate for Lantern Knee System
- Model numbers
- Lot # 25091103BB/ UDI: 00810832032427
- Sold at
- Multiple Retailers
- 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
Pegged drill plates are surgical implants used with knee replacement systems to guide drilling into bone. They are intended to ensure precise placement during procedures.
Why This Is Dangerous
If manufactured out of specification, the drill plate can cause excess bone removal up to 0.008 inches (2.8448 mm), increasing risk of complications during knee surgery.
Industry Context
This recall is not described as part of a broader industry pattern.
Real-World Impact
The recall requires immediate action by healthcare providers to stop using the affected plates and consult Orthalign for next steps.
Practical Guidance
How to identify if yours is affected
- Check Lot # 25091103BB on the device packaging
- Cross-check with surgical records for Lantern Knee System usage
Where to find product info
FDA enforcement page for recall Z-1629-2026; Orthalign instructions to contact for guidance
What timeline to expect
Not specified in recall notice
If the manufacturer is unresponsive
- Escalate to hospital risk management
- Consult FDA recall page for further guidance
- Request assistance from Orthalign through your healthcare provider
How to prevent similar issues
- Verify lot numbers during procurement
- Institute procedure-level checks to ensure only non-recalled devices are used
- Maintain updated recall communications for surgical teams
- Confirm supplier documentation before implanting devices
Documentation advice
Keep copies of recall notice, lot numbers, and correspondence with Orthalign and your surgeon; record patient outcomes and any corrective actions
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
Lot # 25091103BB; UDI: 00810832032427 Manufacturer: Orthalign, Inc. Distribution: US nationwide, including Utah Quantity: 7 units Sold through: Healthcare providers (not retail consumer channels)
Reported Incidents
No injuries or incidents have been reported.
Key Facts
- Pegged drill plate, PREF size 1-5
- Lantern Knee System
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.
