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 Nails
- Model numbers
- Lot Code: Model No 815609440, UDI-DI (01)00887868144530(17)340819(10)66717607, Lot Number 66717607 Model No 815609440, UDI-DI (01)00887868144530(17)341025(10)67031553, Lot Number 67031553
- 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 used in surgical procedures for stabilizing femoral fractures. These medical devices are critical for patients recovering from bone injuries and surgeries.
Why This Is Dangerous
The undersized distal diameter along the length of the shaft can compromise the structural integrity of the implant, leading to fractures that pose significant health risks.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Consumers affected by this recall face immediate health risks that may require surgical intervention, leading to potential delays in recovery and increased medical costs.
Practical Guidance
How to identify if yours is affected
- Check the model number on the product packaging or device itself.
- Verify the lot number against the recall notice.
- Contact your healthcare provider for confirmation.
Where to find product info
Model numbers and lot numbers can typically be found on the packaging or the device itself.
What timeline to expect
Expect a realistic timeline of about 4-6 weeks for processing any refund or replacement requests.
If the manufacturer is unresponsive
- Document all communications with the company.
- Reach out through multiple contact methods if necessary.
- Consider filing a complaint with the FDA if the response is inadequate.
How to prevent similar issues
- Inquire about product recalls before surgery.
- Ensure devices have been tested and certified for safety.
- Consult with your healthcare provider about alternatives.
Documentation advice
Keep all correspondence related to the recall, including emails, letters, and notes from phone calls.
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Product Details
The recall involves the Affixus Antegrade Femoral Nails, model number 815609440. The affected product includes 9 mm nails with a length of 440 mm. These products were distributed nationwide across multiple states in the U.S.
Key Facts
- Recall involves 24 units of Affixus Antegrade Femoral Nails
- Potential for implant fatigue fractures
- Health risks include pain and tissue damage
- Stop use immediately and contact healthcare provider
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Safety Guide
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