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 815509400, UDI-DI (01)00887868143564(17)340821(10)66717555, Lot Number 66717555 Model No 815509400, UDI-DI (01)00887868143564(17)340822(10)66884565, Lot Number 66884565 Model No 815509400, UDI-DI (01)00887868143564(17)350801(10)67379212, Lot Number 67379212
- 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 Nails are medical devices used in orthopedic procedures to stabilize fractured femurs. They are commonly used in surgeries to assist with bone healing and alignment.
Why This Is Dangerous
The undersized distal diameter of the nails can lead to structural weaknesses. This may cause the implant to fracture under normal stress, resulting in significant health risks for the patient.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using this implant face potential surgical risks and complications. Immediate action is necessary to avoid serious health consequences.
Practical Guidance
How to identify if yours is affected
- Check the model number and lot number on your implant.
- Verify the recall status with your healthcare provider or the manufacturer.
- Consult your medical records for further details.
Where to find product info
Model numbers and lot numbers are usually found on the device packaging or in your medical records.
What timeline to expect
Expect a refund or replacement within 4 to 6 weeks after submitting your request.
If the manufacturer is unresponsive
- Follow up with customer service via phone or email.
- Document your correspondence for records.
- Escalate the issue to your healthcare provider if needed.
How to prevent similar issues
- Always verify the recall status of medical devices.
- Consult with your healthcare provider about device safety before surgery.
- Stay informed about product recalls through health organizations.
Documentation advice
Keep all correspondence regarding the recall, including letters from the manufacturer and any medical records related to your implant.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recall involves the Affixus Antegrade Femoral Nails, Model 815509400, with a 9 mm diameter and 400 mm length. These products were distributed nationwide in the U.S., including states such as California and Texas.
Key Facts
- 23 units recalled nationwide
- Potential for implant fatigue fracture
- Risks include pain and tissue damage
- Contact healthcare provider immediately
Browse More Recalls
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 ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.