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 815509380, UDI-DI (01)00887868143557(17)340822(10)66717554, Lot Number 66717554 Model No 815509380, UDI-DI (01)00887868143557(17)340822(10)66884564, Lot Number 66884564 Model No 815509380, UDI-DI (01)00887868143557(17)350421(10)67042197, Lot Number 67042197
- 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 orthopedic implants used in surgeries for bone fixation, particularly in femoral fractures. These implants help stabilize bones during the healing process.
Why This Is Dangerous
The undersized distal diameter along the length of the shaft may lead to fatigue fractures, which can compromise the integrity of the implant and cause significant health issues.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers may experience delays in recovery and potential complications requiring further medical intervention, impacting their overall health and mobility.
Practical Guidance
How to identify if yours is affected
- Check the model number against the recall notice.
- Verify the lot number to confirm if your device is affected.
- Contact your healthcare provider for assistance.
Where to find product info
Model numbers and lot codes can typically be found on the packaging or documentation provided with the device.
What timeline to expect
Expect a refund or replacement timeline of 4-6 weeks after processing your return.
If the manufacturer is unresponsive
- Document all communication attempts with the manufacturer.
- Consider reaching out to the FDA for further assistance.
- Keep records of your attempts for potential legal action if necessary.
How to prevent similar issues
- Research product safety ratings when purchasing medical devices.
- Ensure devices are FDA-approved and regularly check for recalls.
- Consult with healthcare professionals about the best options available.
Documentation advice
Keep copies of all correspondence with the manufacturer and any medical documentation related to the implant.
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Product Details
The recall affects Affixus Antegrade Femoral Nails, Model No 815509380. The product was distributed nationwide in the United States, including states such as California and Texas.
Key Facts
- Recall date: December 2, 2025
- Quantity recalled: 23 units
- Classification: Class II
- Potential risks include pain and tissue damage
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Safety Guide
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