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
- Model numbers
- Lot Code: Model No 815509300, UDI-DI (01)00887868143519(17)340823(10)66717550, Lot Number 66717550
- 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 used in orthopedic surgeries to stabilize fractures in the femur. Surgeons choose this product for its design that facilitates easier implantation and durability under stress.
Why This Is Dangerous
The undersized distal diameter along the length of the nail increases the risk of fatigue fractures. These fractures can lead to serious complications, including pain and the need for additional surgeries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may face significant health risks if they have undergone surgery with an affected implant, necessitating monitoring and possible surgical intervention.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device for 815509300.
- Verify the lot number against 66717550.
- Consult your healthcare provider to confirm if your implant is affected.
Where to find product info
The model and lot numbers are usually found on the packaging and patient information leaflets provided with the device.
What timeline to expect
Expect refund processes to take approximately 4-6 weeks after submitting your information.
If the manufacturer is unresponsive
- Contact the FDA to report unresponsive behavior.
- Document all communication attempts for your records.
- Consider seeking legal advice if necessary.
How to prevent similar issues
- Research the manufacturer's safety record before purchasing medical devices.
- Look for devices with updated safety certifications.
- Consult with healthcare professionals about device alternatives.
Documentation advice
Keep all receipts, recall notifications, and any correspondence with the manufacturer as records.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is the Affixus Antegrade Femoral Nails, Model 815509300. It consists of a 9 mm diameter nail, 300 mm in length, designed for surgical applications. The affected units were distributed nationwide in several states including California and Florida.
Key Facts
- Recall date: December 2, 2025
- Quantity recalled: 11 units
- Potential risks include surgical intervention
- Affected devices distributed nationwide
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.