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 815609380, UDI-DI (01)00887868144509(17)340826(10)66717604, Lot Number 66717604 Model No 815609380, UDI-DI (01)00887868144509(17)340820(10)66892903, Lot Number 66892903
- 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 femoral fractures. Patients and healthcare providers choose this system for its reliability in promoting healing and stabilization during recovery.
Why This Is Dangerous
The defect in the distal diameter of the implants may cause fatigue fractures which compromise the implant's integrity and function. This could lead to severe complications requiring further surgical intervention.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients impacted by this recall may face significant health risks, necessitating medical evaluations and potential surgeries, which can lead to increased healthcare costs and prolonged recovery times.
Practical Guidance
How to identify if yours is affected
- Check the model number on your implant to see if it matches Model No 815609380.
- Verify the lot number against the recalled batches: 66717604 or 66892903.
- Contact your healthcare provider for confirmation and further guidance.
Where to find product info
You can find the model and lot numbers typically on the packaging or the implant itself, often etched or labeled on the side.
What timeline to expect
Expect a resolution process for refunds or replacements to take approximately 4-6 weeks.
If the manufacturer is unresponsive
- Document all attempts to contact the manufacturer.
- Reach out to your healthcare provider for additional support.
- Consider filing a complaint with the FDA if no response is received.
How to prevent similar issues
- When purchasing orthopedic implants, ask for details on the product's safety record.
- Ensure the implants are from reputable manufacturers with strong quality control measures.
- Stay informed about any recalls or safety notices associated with medical devices.
Documentation advice
Keep records of all communications with the manufacturer, healthcare providers, and any receipts or documentation related to the implant.
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Product Details
The recall involves Affixus Antegrade Femoral Nails, Model Number 815609380. The product was distributed nationwide across several states including California, Texas, and Florida. This model does not have a listed price.
Key Facts
- Recalled model: Affixus Antegrade Femoral Nails, Model No 815609380
- Quantity recalled: 24 units
- Recall date: December 2, 2025
- Affected states include AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT
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Safety Guide
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