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: 267-01-000-10-N UDI-DI code: 00190376541471 Lot Number: EM56693
- 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 are designed for use in surgical procedures, often utilized in spine surgeries. These instruments can be either single-use or re-usable, and are intended to be used with surgical navigation systems.
Why This Is Dangerous
The design flaw in the navigated array connection geometry can lead to improper alignment or malfunction during surgery, increasing the risk of surgical errors.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers using these instruments may face serious risks during surgical procedures. Immediate action is necessary to prevent potential complications.
Practical Guidance
How to identify if yours is affected
- Locate the model number: REF 267-01-000-10-N
- Check the UDI-DI code: 00190376541471
- Verify the lot number, EM56693, if applicable
Where to find product info
The model number and UDI-DI code can typically be found on the packaging of the instruments or the instruments themselves.
What timeline to expect
Expect a processing timeline of 4-6 weeks for refunds or replacements.
If the manufacturer is unresponsive
- Contact the manufacturer again via phone or email.
- Document all correspondence and attempts to resolve the issue.
- Consider filing a complaint with the FDA if unresponsive.
How to prevent similar issues
- Always verify that surgical instruments meet safety standards before use.
- Stay informed about recalls in the medical device sector.
- Ask healthcare providers about the safety and reliability of surgical instruments.
Documentation advice
Keep records of purchase, correspondence with the manufacturer, and any relevant photographs of the instruments.
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Product Details
The recalled instruments include the ATEC Lateral Navigation Disc Prep Instruments, REF 267-01-000-10-N. They are intended for surgical procedures and can be non-sterile or sterile packaged. The instruments were distributed nationwide in various states including AZ, CA, FL, IL, IN, MA, MI, MO, NC, NH, NY, TN, TX, and VA.
Key Facts
- Recall date: January 2, 2026
- Distributed nationwide in 12 states
- High hazard level
- Contact Alphatec Spine for guidance
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Safety Guide
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