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 815609400, UDI-DI (01)00887868144516(17)340818(10)66717605, Lot Number 66717605 Model No 815609400, UDI-DI (01)00887868144516(17)340826(10)66892904, Lot Number 66892904 Model No 815609400, UDI-DI (01)00887868144516(17)341024(10)67031552, Lot Number 67031552
- 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 bone fractures. Patients often receive these implants following severe fractures or surgical procedures to ensure proper healing.
Why This Is Dangerous
The undersized distal diameter of the implants can lead to fatigue fractures, resulting in serious complications that may require additional surgery. This defect compromises the integrity of the implant, posing significant health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall may cause significant concern for patients who have undergone surgery with these implants. The potential for serious health complications necessitates immediate action.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recalled list.
- Verify the lot number associated with your implant.
- Consult your healthcare provider if unsure about your device.
Where to find product info
Model numbers and lot codes are typically located on the packaging or documentation provided with the implant.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks.
If the manufacturer is unresponsive
- Document all communications with the company.
- Consider reaching out to regulatory bodies for assistance.
How to prevent similar issues
- Inquire about the quality and testing of medical devices before surgery.
- Ask healthcare providers about potential risks associated with implants.
Documentation advice
Keep all correspondence with Zimmer Inc. and records of your implant details for future reference.
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Product Details
The recalled product is the Affixus Antegrade Femoral Nail, model number 815609400. It consists of a 9 mm diameter and 400 mm length nail. Sold nationwide in various states, it is part of Zimmer's medical device lineup.
Key Facts
- Quantity recalled: 24 units
- Recall date: December 2, 2025
- High risk of implant fatigue fractures
- Distribution across US states including CA, FL, TX
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Safety Guide
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