Quick Facts at a Glance
- Recall Date
- November 10, 2025
- Hazard Level
- HIGH
- Brand
- Waldemar Link GmbH & Co. KG
- Category
- Health & Personal Care
- Sold At
- Unknown
- Geographic Scope
- 3 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
- Waldemar Link GmbH & Co. KG
- Product type
- Knee Fusion Nail
- Model numbers
- Item Number: 15-0028/08, UDI-DI: 04026575175222, Lot Number: 2535004
- Sold at
- Unknown
- Where affected
- AL, GA, TX
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
November 10, 2025
Reported by FDA DEVICE
December 17, 2025
RecallRadar source check
December 24, 2025
Consumer action
Use the official remedy and keep documentation.
Hazard Information
The device has been delivered with a preassembled locking screw that had been inserted from the wrong side into the male taper of the femoral component.
What You Should Do
Patients and healthcare providers should stop using this device immediately. Follow the recall instructions provided by the manufacturer. Contact Waldemar Link GmbH & Co. KG (Mfg Site) or your healthcare provider for instructions. Notification method: E-Mail
About This Product
The Endo Model Knee Fusion Nail is a critical component used in limb salvage replacement surgeries. It is designed to provide stability and support in knee reconstruction procedures.
Why This Is Dangerous
The hazard arises from a preassembled locking screw inserted incorrectly, which can compromise the integrity of the device. This flaw can lead to device failure during use, posing serious risks to patients.
Industry Context
This recall is not part of a broader industry pattern.
Real-World Impact
Patients using this device may face serious health risks due to potential failure. Immediate action is required to prevent complications, making this recall urgent.
Practical Guidance
How to identify if yours is affected
- Check for item number 15-0028/08, UDI-DI 04026575175222, or lot number 2535004 on the product packaging.
- Contact your healthcare provider to confirm if your device is affected.
- Review any communication from your healthcare provider or manufacturer regarding this recall.
Where to find product info
You can find the item number, UDI-DI, and lot number on the packaging or accompanying documentation of the device.
What timeline to expect
Expect a realistic timeline of 4-6 weeks for processing refunds or replacements after contacting the manufacturer.
If the manufacturer is unresponsive
- Reach out again to Waldemar Link GmbH & Co. KG via the email provided in the recall notice.
- Document all attempts to contact the manufacturer for your records.
How to prevent similar issues
- When purchasing medical devices, ensure they come from reputable manufacturers with a history of safety compliance.
- Check for recent recalls on the FDA website before using any medical device.
- Seek advice from healthcare professionals on the latest safety information regarding medical devices.
Documentation advice
Keep all correspondence, receipts, and documentation related to the recall and your device for reference.
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
Product Details
The recalled product is the Endo Model Knee Fusion Nail SK, coupling component, right, modular, measuring 68 mm with a taper of 10/12. It has item number 15-0028/08, UDI-DI 04026575175222, and lot number 2535004. It was distributed to healthcare providers in Alabama, Georgia, and Texas.
Key Facts
- Class II recall due to assembly error
- Distributed in AL, GA, TX
- Immediate stop-use advised
- Contact manufacturer for instructions
Browse More Recalls
Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: What to Do When You Find a Recalled ProductGet Alerts for Health & Personal Care Recalls
Get instant alerts for recalls that affect you. Free forever.