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 815509440, UDI-DI (01)00887868143588(17)340820(10)66717557, Lot Number 66717557 Model No 815509440, UDI-DI (01)00887868143588(17)350422(10)67101279, Lot Number 67101279 Model No 815509440, UDI-DI (01)00887868143588(17)350419(10)67101280, Lot Number 67101280
- 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 for the stabilization of fractures in the femur. Surgeons typically use them in orthopedic procedures to ensure proper alignment and healing of bone fractures.
Why This Is Dangerous
The defect in the distal diameter of the implants can lead to fatigue fractures, which may compromise the stability of the bone and lead to further complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using the affected implants face serious health risks, including the potential need for additional surgeries to address complications.
Practical Guidance
How to identify if yours is affected
- Check your medical records or contact your healthcare provider to see if you received an Affixus Antegrade Femoral Nail.
- Look for the model number 815509440 on your medical device documentation.
- If unsure, consult your orthopedic surgeon to verify the type of implant used.
Where to find product info
You can find the model number and lot codes on your surgical records or the device packaging if available.
What timeline to expect
Expect a timeline of 4-6 weeks for refund processing or further instructions from the manufacturer.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Consider contacting the FDA for further guidance on unresolved recall issues.
- Reach out to a consumer advocacy group if necessary.
How to prevent similar issues
- When selecting medical implants, inquire about the manufacturer's safety record and recall history.
- Always follow up with your healthcare provider if you experience any unusual symptoms post-surgery.
- Stay informed about recalls and safety alerts regarding medical devices.
Documentation advice
Keep all records related to your implant, including surgical notes, correspondence regarding the recall, and any symptoms experienced.
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Product Details
This recall affects the Affixus Antegrade Femoral Nails, model number 815509440. The product is 9 mm in diameter and 440 mm in length. The affected implants were distributed nationwide in various states.
Key Facts
- Recall date: December 2, 2025
- Quantity recalled: 22 units
- Risk of implant fatigue fracture
- Potential need for surgical intervention
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Safety Guide
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