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
- Model numbers
- Lot Code: Model No 815609360, UDI-DI (01)00887868144493(17)340820(10)66717603, Lot Number 66717603 Model No 815609360, UDI-DI (01)00887868144493(17)340905(10)66892902, Lot Number 66892902 Model No 815609360, UDI-DI (01)00887868144493(17)341030(10)67031550, Lot Number 67031550
- 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 Nail is a medical implant used in orthopedic surgeries to stabilize fractures in the femur. Surgeons choose this device for its design, which aids in proper healing of fractures through internal fixation.
Why This Is Dangerous
The implant has an undersized distal diameter which can lead to fatigue fractures under stress. Such fractures pose serious health risks, including pain and the potential need for additional surgeries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers with the affected implants may face significant health risks, including the need for corrective surgery and prolonged recovery times.
Practical Guidance
How to identify if yours is affected
- Locate the model number and lot number on the device packaging.
- Cross-check the model and lot numbers against the recall list.
- Contact your healthcare provider for confirmation.
Where to find product info
The model and lot numbers are typically found on the device packaging or in the surgical records provided by your healthcare provider.
What timeline to expect
Expect a response regarding refunds or replacements within 4-6 weeks after contacting the manufacturer.
If the manufacturer is unresponsive
- Follow up with the manufacturer via phone or email.
- Report the issue to the FDA if there is no response.
How to prevent similar issues
- Consult with healthcare professionals about the latest medical device safety records before surgery.
- Research the manufacturer's history of recalls and safety issues before using a medical implant.
- Ensure that your healthcare provider is aware of all recalls related to surgical implants.
Documentation advice
Keep records of all communications regarding the recall, including dates, names of representatives, and any written correspondence.
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Product Details
The recalled product is the Affixus Antegrade Femoral Nail, model number 815609360, with a diameter of 9 mm and a length of 360 mm. It was distributed nationwide in the US, including states such as California and Texas. The device was available through multiple retailers.
Key Facts
- Affected implants may fracture
- Potential health risks include pain and tissue damage
- Immediate action required from healthcare providers
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Safety Guide
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