HIGH

Alphatec Spine Recalls Surgical Instruments Over Connection Issue

Alphatec Spine recalled 7 units of Lateral Navigation Disc Prep Instruments on January 2, 2026, due to a design flaw. The incorrect navigated array connection geometry poses a high hazard risk in surgical settings. Healthcare providers and patients must stop using the devices immediately.

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

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

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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

  1. Check if the model number is 266-01-000-10-N.
  2. Verify the UDI-DI code: 00190376476179.
  3. 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.

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

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 Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
Model/Catalog Number: 266-01-000-10-N UDI-DI code: 00190376476179 Lot Number: EM49968
Affected States
ALL
Report Date
February 18, 2026
Recall Status
ACTIVE

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