Waldemar Link GmbH & Co. KG recalled 18 units of the Endo Model Knee Fusion Nail SK on November 10, 2025. The device features a preassembled locking screw incorrectly inserted, posing a high risk of failure. Affected units were distributed in Alabama, Georgia, and Texas.
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.
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
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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.
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.
This recall is not part of a broader industry pattern.
Patients using this device may face serious health risks due to potential failure. Immediate action is required to prevent complications, making this recall urgent.
You can find the item number, UDI-DI, and lot number on the packaging or accompanying documentation of the device.
Expect a realistic timeline of 4-6 weeks for processing refunds or replacements after contacting the manufacturer.
Keep all correspondence, receipts, and documentation related to the recall and your device for reference.
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.
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