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
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
- Zimmer
- Product type
- Femoral Nail System
- Model numbers
- Lot Code: Model No 815609300, UDI-DI (01)00887868144462(17)340826(10)66717600, Lot Number 66717600
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
December 2, 2025
Reported by FDA DEVICE
December 31, 2025
RecallRadar source check
April 13, 2026
Consumer action
Use the official remedy and keep documentation.
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
About This Product
The Affixus Antegrade Femoral Nail is a medical device used in orthopedic surgery to stabilize femur fractures. Surgeons choose this device for its ability to provide internal fixation to enhance healing.
Why This Is Dangerous
The defect in the distal diameter of the nail can lead to fatigue fractures, causing serious complications that may require surgical intervention and can negatively affect recovery.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Users of the affected devices may face significant health risks, necessitating additional surgeries and causing emotional distress.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recalled models.
- Verify the lot number to ensure it matches the affected lot.
- Contact your healthcare provider for confirmation and safety assessment.
Where to find product info
You can find the model number and lot number on the packaging or directly on the device.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements.
If the manufacturer is unresponsive
- Contact Zimmer, Inc. directly via their customer service line.
- Document all communication and follow up if necessary.
How to prevent similar issues
- Consider alternative medical devices with proven safety records.
- Ensure that any medical device is FDA approved before use.
- Consult with healthcare providers about the latest safety recalls.
Documentation advice
Keep a record of all communications, including emails and letters from the manufacturer, and photographs of the device if possible.
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Product Details
The recall involves Affixus Antegrade Femoral Nails, Model No 815609300. The product is 9 mm in diameter and 300 mm in length. The affected units were distributed in several states across the U.S.
Key Facts
- Recall date: December 2, 2025
- Quantity recalled: 11 units
- Distributed in multiple U.S. states
- High hazard level classification
- Immediate stop-use advisory
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Safety Guide
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