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 Nailing System
- Model numbers
- Lot Code: Model No 815609340, UDI-DI (01)00887868144486(17)340904(10)66717602, Lot Number 66717602 Model No 815609340, UDI-DI (01)00887868144486(17)340904(10)66892901, Lot Number 66892901
- 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 Nailing System is a medical device used in orthopedic surgeries for stabilizing femur fractures. Surgeons choose this device for its design and efficiency in implanting nails into the femur.
Why This Is Dangerous
The recall is due to potential undersizing of the distal diameter of the implant, which may lead to fatigue fractures. Such fractures can compromise the integrity of the implant and harm surrounding tissues.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients with the affected device may face significant health risks, including the possibility of needing additional surgery due to implant failure.
Practical Guidance
How to identify if yours is affected
- Locate the model number on your implant.
- Verify if it matches Model No 815609340.
- Check the lot numbers: 66717602 or 66892901.
Where to find product info
The model number and lot number can usually be found on the implant packaging or in the device records provided by your healthcare provider.
What timeline to expect
Expect processing for refunds or replacements to take around 4-8 weeks.
If the manufacturer is unresponsive
- Document your communications with the manufacturer.
- Consider escalating your issue to regulatory bodies if necessary.
How to prevent similar issues
- When purchasing medical devices, ensure they are from reputable manufacturers with good safety records.
- Check for recent recalls or safety notices before use.
Documentation advice
Keep all receipts, correspondence, and documentation related to the implant and recall for your records.
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Product Details
The recalled product is the Affixus Antegrade Femoral Nails, Model/Catalog Number 815609340. The affected size is 9 mm with a length of 340 mm. These products were distributed nationwide in several states including California, Texas, and Florida.
Key Facts
- Recalled product: Affixus Antegrade Femoral Nails
- Recall date: December 2, 2025
- Nationwide distribution in multiple states
- Potential for serious health risks
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Safety Guide
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