HIGH

Zimmer Recalls Affixus Antegrade Femoral Nails Due to Fracture Risk

Zimmer recalled 24 Affixus Antegrade Femoral Nails on December 2, 2025, due to potential implant fatigue fractures. The defective implants could cause severe health risks, including pain, tissue damage, and the need for additional surgery. Healthcare providers and patients must cease use immediately and follow recall protocols.

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 surgical procedures for stabilizing femoral fractures. These medical devices are critical for patients recovering from bone injuries and surgeries.

Why This Is Dangerous

The undersized distal diameter along the length of the shaft can compromise the structural integrity of the implant, leading to fractures that pose significant health risks.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers affected by this recall face immediate health risks that may require surgical intervention, leading to potential delays in recovery and increased medical costs.

Practical Guidance

How to identify if yours is affected

  1. Check the model number on the product packaging or device itself.
  2. Verify the lot number against the recall notice.
  3. Contact your healthcare provider for confirmation.

Where to find product info

Model numbers and lot numbers can typically be found on the packaging or the device itself.

What timeline to expect

Expect a realistic timeline of about 4-6 weeks for processing any refund or replacement requests.

If the manufacturer is unresponsive

  • Document all communications with the company.
  • Reach out through multiple contact methods if necessary.
  • Consider filing a complaint with the FDA if the response is inadequate.

How to prevent similar issues

  • Inquire about product recalls before surgery.
  • Ensure devices have been tested and certified for safety.
  • Consult with your healthcare provider about alternatives.

Documentation advice

Keep all correspondence related to the recall, including emails, letters, and notes from phone calls.

Product Details

The recall involves the Affixus Antegrade Femoral Nails, model number 815609440. The affected product includes 9 mm nails with a length of 440 mm. These products were distributed nationwide across multiple states in the U.S.

Key Facts

  • Recall involves 24 units of Affixus Antegrade Femoral Nails
  • Potential for implant fatigue fractures
  • Health risks include pain and tissue damage
  • Stop use immediately and contact healthcare provider

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

Brand
Model Numbers
Lot Code: Model No 815609440
UDI-DI (01)00887868144530(17)340819(10)66717607
Lot Number 66717607 Model No 815609440
UDI-DI (01)00887868144530(17)341025(10)67031553
Lot Number 67031553
Affected States
ALL
Report Date
December 31, 2025
Recall Status
ACTIVE

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