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 Nailing System
- Model numbers
- Lot Code: Model No 815509340, UDI-DI (01)00887868143533(17)340822(10)66717552, Lot Number 66717552 Model No 815509340, UDI-DI (01)00887868143533(17)340826(10)66884562, Lot Number 66884562
- 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 Nailing System is used to stabilize femur fractures. It is designed for patients requiring surgical intervention for bone stabilization.
Why This Is Dangerous
Implants may have an undersized distal diameter, risking fatigue fractures that can lead to severe complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients may face health risks that could require further surgeries, leading to additional medical costs and recovery time.
Practical Guidance
How to identify if yours is affected
- Check the model number and lot numbers against the recall information provided by the manufacturer.
- Inspect any documentation received with the implant for relevant details.
- Contact your healthcare provider to verify if your device is affected.
Where to find product info
You can typically find the model number and lot number on the packaging or the device itself.
What timeline to expect
Expect a refund or replacement process to take approximately 4 to 6 weeks.
If the manufacturer is unresponsive
- Document all correspondence with the manufacturer.
- Contact your healthcare provider for further assistance.
- Consider filing a complaint with the FDA if there is no response.
How to prevent similar issues
- Ensure to verify the safety and recall history of medical devices before use.
- Consult with healthcare providers about the latest information on implant safety.
Documentation advice
Keep any receipts, correspondence about the recall, and photographs of the implant for your records.
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Product Details
The recall includes Affixus Antegrade Femoral Nails, specifically model number 815509340. The affected implants feature a distal diameter that may be undersized along the shaft. These devices were distributed across various states including Texas, California, and Florida.
Key Facts
- Recall Date: December 2, 2025
- Quantity Recalled: 22 units
- Distribution: Nationwide across 14 states
- Health Risk: Potential implant fatigue fracture
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Safety Guide
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