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 815509360, UDI-DI (01)00887868143540(17)340917(10)66717553, Lot Number 66717553 Model No 815509360, UDI-DI (01)00887868143540(17)340823(10)66884563, Lot Number 66884563
- 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 surgery to stabilize fractures in the femur. Surgeons and healthcare providers typically use these implants for patients recovering from femoral fractures.
Why This Is Dangerous
The implants may have an undersized distal diameter, which can increase the risk of fatigue fractures. Such fractures can lead to severe complications including pain and the need for additional surgeries.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using the affected implants may face health risks that require surgical intervention and can suffer from pain or complications if not addressed promptly.
Practical Guidance
How to identify if yours is affected
- Check the model number on your implant packaging or device.
- Verify the lot number against the recall list provided by Zimmer.
- Consult your healthcare provider for confirmation.
Where to find product info
Model numbers and lot codes can typically be found on the packaging or directly on the implant itself, usually near the UDI label.
What timeline to expect
Expect a refund or replacement to take 4-8 weeks following the recall process.
If the manufacturer is unresponsive
- Contact Zimmer directly for updates.
- Document all communications and attempts to resolve the issue.
- File a complaint with the FDA if necessary.
How to prevent similar issues
- When purchasing implants, inquire about safety recalls and manufacturing standards.
- Ask about the history of the product and any design changes made over time.
- Look for products with established safety records.
Documentation advice
Keep a record of all communications with the manufacturer, including letters, emails, and phone call notes.
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Product Details
The recall includes Affixus Antegrade Femoral Nails, model 815509360. The implants were distributed nationwide in states including California and Texas. The affected product has a 9 mm diameter and a length of 360 mm.
Key Facts
- Recall date: December 2, 2025
- Quantity recalled: 22 units
- Affected states: AL, AZ, CA, FL, IN, KY, MA, MO, MT, NC, NM, RI, TX, UT
- Health risks include local tissue reaction and surgical intervention
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Safety Guide
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