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 815609420, UDI-DI (01)00887868144523(17)340818(10)66717606, Lot Number 66717606 Model No 815609420, UDI-DI (01)00887868144523(17)340913(10)66892905, Lot Number 66892905
- 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 used in orthopedic surgeries for stabilizing fractures in the femur. It is commonly utilized in procedures related to trauma or orthopedic conditions requiring internal fixation.
Why This Is Dangerous
The hazard arises from an undersized distal diameter in the implants, which increases the risk of fatigue fractures during use. Such fractures can lead to significant complications requiring additional surgical intervention.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers using the affected implants face serious health risks, including pain and the potential need for surgical repair, which can lead to significant healthcare costs and recovery time.
Practical Guidance
How to identify if yours is affected
- Locate the model number 815609420 on the implant packaging or device.
- Check the lot numbers (66717606, 66892905) associated with your device.
- Contact your healthcare provider to verify if your device is affected.
Where to find product info
Model numbers and lot codes can typically be found on the device packaging or accompanying documentation.
What timeline to expect
Expect a timeline of 4-6 weeks for processing refunds or replacements for affected devices.
If the manufacturer is unresponsive
- Contact Zimmer directly for assistance with the recall.
- Keep a record of all attempts to reach your healthcare provider.
How to prevent similar issues
- Always verify the model and lot numbers against recall notices when receiving medical devices.
- Consult healthcare professionals for the latest safety information on medical implants.
Documentation advice
Document all correspondence related to the recall, including emails and phone call records. Keep any medical documentation related to the use of the device.
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Product Details
The recall involves Affixus Antegrade Femoral Nails, model number 815609420, with a diameter of 9 mm and a length of 420 mm. The affected products were distributed nationwide across multiple states.
Key Facts
- Recall Date: December 2, 2025
- High Hazard Level
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Safety Guide
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