HIGH

Affixus Antegrade Femoral Nails Recalled Over Fracture Risk

Zimmer, Inc. recalled 23 units of the Affixus Antegrade Femoral Nails on December 2, 2025. The implants may have an undersized distal diameter, risking implant fatigue fracture. This defect can cause severe health issues, including pain and tissue damage requiring surgery.

Quick Facts at a Glance

Recall Date
December 2, 2025
Hazard Level
HIGH
Brand
Zimmer
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

Affected implants may have undersized distal diameter along length of the shaft, which could lead to implant fatigue fracture. Potential health risk if implant fatigue fracture occurs include adverse local tissue reaction, pain or ache, non-union or malunion, or tissue damage necessitating surgical intervention.

What You Should Do

Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Zimmer, Inc. or your healthcare provider for instructions. Notification method: Letter

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About This Product

The Affixus Antegrade Femoral Nails are used in orthopedic surgery for stabilizing fractures in the femur. Surgeons choose this product for its design and compatibility with various surgical techniques.

Why This Is Dangerous

The hazard arises from the potential for an undersized distal diameter, which can lead to fractures of the implant under stress. Such fractures pose serious health risks, including the need for additional surgeries.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Patients with the affected implants may face significant health risks and potential surgical interventions if not addressed promptly.

Practical Guidance

How to identify if yours is affected

  1. Check the model and lot number against the recall notice.
  2. Contact your healthcare provider for verification of your implant.
  3. Look for any symptoms like pain or discomfort at the implant site.

Where to find product info

Model and lot numbers are usually engraved on the implant or available in your medical records.

What timeline to expect

Expect a refund or replacement within 4-6 weeks after contacting Zimmer, Inc.

If the manufacturer is unresponsive

  • Document all correspondence with the company.
  • Follow up with your healthcare provider for guidance.
  • Consider filing a complaint with the FDA if necessary.

How to prevent similar issues

  • Verify safety certifications for medical devices.
  • Consult with healthcare providers about recalls before surgery.
  • Stay informed about product recalls through trusted sources.

Documentation advice

Keep records of your implant details, any symptoms experienced, and correspondence with the manufacturer.

Product Details

The recalled product is the Affixus Antegrade Femoral Nails, Model/Catalog Number 815609320. The implants were distributed nationwide across several states including California and Texas. They are not priced in the recall data.

Key Facts

  • Recalled Model: Affixus Antegrade Femoral Nails Model 815609320
  • Quantity Recalled: 23 units
  • Distribution: Nationwide in multiple states
  • Hazard: Risk of implant fatigue fracture
  • Health Risks: Adverse local tissue reactions, pain, tissue damage

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 Details

Brand
Model Numbers
Lot Code: Model No 815609320
UDI-DI (01)00887868144479(17)340826(10)66717601
Lot Number 66717601 Model No 815609320
UDI-DI (01)00887868144479(17)340820(10)66892900
Lot Number 66892900
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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