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 Implant
- Model numbers
- Lot Code: Model No 815809280, UDI-DI (01)00887868584763(17)350416(10)67066287, Lot Number 67066287
- 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 for stabilizing fractures in the femur. Surgeons typically use this device in orthopedic procedures to promote proper healing of bone fractures.
Why This Is Dangerous
The defect in the device may lead to an undersized distal diameter, increasing the risk of implant fatigue fractures. This can result in serious health 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 affected by this recall may face significant health risks and potential surgical interventions, impacting recovery time and overall well-being.
Practical Guidance
How to identify if yours is affected
- Check the model number on the device: 815809280
- Verify the lot number: 67066287
- Consult with your healthcare provider regarding your specific implant.
Where to find product info
The model and lot numbers are typically found on the packaging or the device label itself.
What timeline to expect
Expect a response from the manufacturer regarding the recall process within 4-6 weeks.
If the manufacturer is unresponsive
- Follow up with Zimmer, Inc. via phone or email for updates.
- Contact your healthcare provider for additional assistance.
How to prevent similar issues
- When selecting medical devices, ensure they meet safety standards and have thorough testing documentation.
- Consult with healthcare professionals about the safest options for your specific needs.
Documentation advice
Keep all receipts, correspondence with the manufacturer, and any medical records related to your device.
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Product Details
The recalled product is the Affixus Antegrade Femoral Nail, model number 815809280, measuring 9 mm by 280 mm. This product was distributed nationwide in states including Florida, Texas, and California. Specific lot number is 67066287.
Key Facts
- Recall Date: December 2, 2025
- Affected Model: Affixus Antegrade Femoral Nail, model 815809280
- Potential health risks: implant fatigue fracture, pain, tissue damage.
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