Quick Facts at a Glance
- Recall Date
- January 2, 2026
- Hazard Level
- HIGH
- Brand
- Alphatec Spine
- 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
- Alphatec Spine
- Product type
- Surgical Instruments
- Model numbers
- Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
January 2, 2026
Reported by FDA DEVICE
February 18, 2026
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Due a design issue where the navigated array connection geometry is incorrect.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Alphatec Spine, Inc. or your healthcare provider for instructions. Notification method: Letter
About This Product
The ATEC Lateral Navigation Disc Prep Instruments assist in surgical procedures by providing navigation support. Surgeons rely on these devices for accurate placements during surgery, making their reliability critical.
Why This Is Dangerous
The design issue with the navigated array connection geometry can result in misalignment during surgical procedures, potentially leading to severe consequences for patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients and healthcare providers face immediate safety concerns due to the risk associated with the affected instruments. The recall may disrupt scheduled surgical procedures.
Practical Guidance
How to identify if yours is affected
- Check if the model number is 266-01-000-10-N.
- Verify the UDI-DI code: 00190376476179.
- Look for the lot number EM49968 on the packaging.
Where to find product info
The model number and UDI-DI code can typically be found on the packaging or the device itself.
What timeline to expect
Expect a refund or replacement processing time of approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Consider filing a complaint with the FDA.
- Seek legal advice if necessary.
How to prevent similar issues
- Always check for recalls on medical devices before use.
- Ensure that devices comply with current safety regulations.
- Consult with healthcare providers about device safety before procedures.
Documentation advice
Keep copies of all relevant correspondence, receipts, and any communications regarding the recall.
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Product Details
The recalled product is the ATEC Lateral Navigation Disc Prep Instruments, specifically the LIF NAV, OSTEOTOME 10mm REF 266-01-000-10-N. These instruments are designed for surgical procedures and may be sterile or non-sterile. They were distributed nationwide in the U.S. states of AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
Key Facts
- Recall date: January 2, 2026
- Quantity recalled: 7 units
- Distribution: Nationwide in U.S.
- Hazard level: High
- Immediate action required
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Safety Guide
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