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 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.
The device has a preassembled locking screw that was inserted from the wrong side into the male taper of the femoral component. This improper assembly can lead to device failure during use, potentially resulting in serious injury to patients.
There have been no reported injuries or deaths associated with this recall. The device is classified as a Class II recall, indicating a high risk of injury.
Patients and healthcare providers must stop using this device immediately. Follow the recall instructions provided by the manufacturer and contact Waldemar Link GmbH & Co. KG or a healthcare provider for further guidance.
For further assistance, contact Waldemar Link GmbH & Co. KG via email as detailed in the recall notice. More information can be found at the FDA recall page.
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