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 815509420, UDI-DI (01)00887868143571(17)340920(10)66717556, Lot Number 66717556 Model No 815509420, UDI-DI (01)00887868143571(17)340920(10)66884566, Lot Number 66884566
- 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 to stabilize fractures of the femur. It is commonly used in orthopedic surgeries to provide structural support during healing.
Why This Is Dangerous
The undersized distal diameter can lead to fatigue fractures, which compromise the implant's integrity and may require additional surgical interventions to correct.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
This recall poses significant risks to patients who may experience severe health complications, adding urgency for immediate action.
Practical Guidance
How to identify if yours is affected
- Check the model number on your implant: 815509420.
- Verify the lot number: 66717556 or 66884566.
- Consult your healthcare provider if you are unsure about the model or lot number.
Where to find product info
The model and lot numbers can typically be found on the packaging or documentation provided with the implant.
What timeline to expect
Expect a processing timeline of 4-6 weeks for refunds or replacements after contacting the manufacturer.
If the manufacturer is unresponsive
- Document all communications with the manufacturer.
- Follow up via phone or email if there is no response within a week.
- Contact your healthcare provider for additional support.
How to prevent similar issues
- When selecting medical devices, ensure they have recent safety certifications.
- Research recalls and safety histories of medical devices before use.
- Discuss potential risks of implants with your healthcare provider.
Documentation advice
Keep all receipts, correspondence, and any medical records related to the implant for your records.
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Product Details
The recall involves the Affixus Antegrade Femoral Nails, model number 815509420. These implants were distributed nationwide in various states, including California and Texas. There is no price mentioned for the product.
Key Facts
- Recall date: December 2, 2025
- Potential health risks include pain and tissue damage
- Stop using the product immediately
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Safety Guide
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