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 Nails
- Model numbers
- Lot Code: Model No 815609320, UDI-DI (01)00887868144479(17)340826(10)66717601, Lot Number 66717601 Model No 815609320, UDI-DI (01)00887868144479(17)340820(10)66892900, Lot Number 66892900
- 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 surgery for stabilizing fractures in the femur. Surgeons choose this product for its design and compatibility with various surgical techniques.
Why This Is Dangerous
The hazard arises from the potential for an undersized distal diameter, which can lead to fractures of the implant under stress. Such fractures pose serious health risks, including the need for additional surgeries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients with the affected implants may face significant health risks and potential surgical interventions if not addressed promptly.
Practical Guidance
How to identify if yours is affected
- Check the model and lot number against the recall notice.
- Contact your healthcare provider for verification of your implant.
- Look for any symptoms like pain or discomfort at the implant site.
Where to find product info
Model and lot numbers are usually engraved on the implant or available in your medical records.
What timeline to expect
Expect a refund or replacement within 4-6 weeks after contacting Zimmer, Inc.
If the manufacturer is unresponsive
- Document all correspondence with the company.
- Follow up with your healthcare provider for guidance.
- Consider filing a complaint with the FDA if necessary.
How to prevent similar issues
- Verify safety certifications for medical devices.
- Consult with healthcare providers about recalls before surgery.
- Stay informed about product recalls through trusted sources.
Documentation advice
Keep records of your implant details, any symptoms experienced, and correspondence with the manufacturer.
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Product Details
The recalled product is the Affixus Antegrade Femoral Nails, Model/Catalog Number 815609320. The implants were distributed nationwide across several states including California and Texas. They are not priced in the recall data.
Key Facts
- Recalled Model: Affixus Antegrade Femoral Nails Model 815609320
- Quantity Recalled: 23 units
- Distribution: Nationwide in multiple states
- Hazard: Risk of implant fatigue fracture
- Health Risks: Adverse local tissue reactions, pain, tissue damage
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Safety Guide
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