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 Nail Implant
- Model numbers
- Lot Code: Model No 815509320, UDI-DI (01)00887868143526(17)340820(10)66717551, Lot Number 66717551 Model No 815509320, UDI-DI (01)00887868143526(17)340821(10)66884561, Lot Number 66884561
- 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 for stabilizing femur fractures. Surgeons typically use these devices in procedures to repair complex fractures in the femur.
Why This Is Dangerous
The undersized distal diameter along the shaft increases the risk of fatigue fractures, which can compromise the integrity of the implant and lead to further complications.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall poses significant health risks to patients requiring surgical intervention if fractures occur, leading to potential pain and complications.
Practical Guidance
How to identify if yours is affected
- Check the model number: 815509320
- Verify the lot number: 66717551 or 66884561
- Contact your healthcare provider for confirmation.
Where to find product info
The model and lot numbers are typically found on the packaging or the device itself.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks.
If the manufacturer is unresponsive
- Document all correspondence and attempts to contact Zimmer, Inc.
- Consider reaching out to the FDA for additional guidance.
How to prevent similar issues
- Look for safety certifications when purchasing medical devices.
- Consult with healthcare providers about the latest product recalls before procedures.
- Research the manufacturer’s history regarding safety and recalls.
Documentation advice
Keep records of all communications with the manufacturer, including emails and letters regarding the recall.
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Product Details
The recall affects 22 units of Affixus Antegrade Femoral Nails, Model 815509320. These were distributed nationwide in states including California and Florida. The implants are 9 mm in diameter and 320 mm in length.
Key Facts
- Recall date: December 2, 2025
- Quantity recalled: 22 units
- Nationwide distribution in the US
- Risk of implant fatigue fractures
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Safety Guide
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