HIGH

Zimmer Recalls Affixus Antegrade Femoral Nails Over Fracture Risk

Zimmer Inc. recalled 23 units of the Affixus Antegrade Femoral Nails on December 2, 2025. Affected implants may have an undersized distal diameter, leading to potential health risks. Patients should stop using the devices immediately and contact their healthcare provider.

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 orthopedic implants used in surgeries for bone fixation, particularly in femoral fractures. These implants help stabilize bones during the healing process.

Why This Is Dangerous

The undersized distal diameter along the length of the shaft may lead to fatigue fractures, which can compromise the integrity of the implant and cause significant health issues.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may experience delays in recovery and potential complications requiring further medical intervention, impacting their overall health and mobility.

Practical Guidance

How to identify if yours is affected

  1. Check the model number against the recall notice.
  2. Verify the lot number to confirm if your device is affected.
  3. Contact your healthcare provider for assistance.

Where to find product info

Model numbers and lot codes can typically be found on the packaging or documentation provided with the device.

What timeline to expect

Expect a refund or replacement timeline of 4-6 weeks after processing your return.

If the manufacturer is unresponsive

  • Document all communication attempts with the manufacturer.
  • Consider reaching out to the FDA for further assistance.
  • Keep records of your attempts for potential legal action if necessary.

How to prevent similar issues

  • Research product safety ratings when purchasing medical devices.
  • Ensure devices are FDA-approved and regularly check for recalls.
  • Consult with healthcare professionals about the best options available.

Documentation advice

Keep copies of all correspondence with the manufacturer and any medical documentation related to the implant.

Product Details

The recall affects Affixus Antegrade Femoral Nails, Model No 815509380. The product was distributed nationwide in the United States, including states such as California and Texas.

Key Facts

  • Recall date: December 2, 2025
  • Quantity recalled: 23 units
  • Classification: Class II
  • Potential risks include pain and 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 815509380
UDI-DI (01)00887868143557(17)340822(10)66717554
Lot Number 66717554 Model No 815509380
UDI-DI (01)00887868143557(17)340822(10)66884564
Lot Number 66884564 Model No 815509380
+2 more
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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