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
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
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.
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 instant alerts for recalls that affect you. Free forever.
Waldemar Link GmbH & Co. KG recalls 74 Embrace Drill Tower devices distributed in 15 U.S. states. The recall notes mixed-up article numbers in the overview of the instruments. The surgical steps are correct. Stop using the device immediately and follow manufacturer instructions.
Waldemar Link GmbH & Co. KG recalled 75 Embrace Shoulder Drill Tower devices distributed to U.S. hospitals after discovering mixed-up article numbers in the device overview. The surgical steps are correct, but the overview labeling is inaccurate. Healthcare providers should stop using the device immediately and follow manufacturer recall instructions sent by email.
Waldemar Link GmbH & Co. KG recalled 2 units of Endo-Model Replacement Plateau with Item Number 15-0027/11. The defect could cause the bushing to detach from the screw shaft after a longitudinal fracture. Health care providers and patients should stop using the device and await manufacturer instructions.
Waldemar Link GmbH & Co. KG recalled 49 SL Connection Components sold worldwide after reports of potential detachment of the bushing from the screw shaft. A longitudinal fracture could occur, posing serious risks to patients. Patients and healthcare providers should stop using the device immediately and follow recall instructions.
Waldemar Link GmbH & Co. KG recalls its Endo-Model Replacement Plateau implant. Three units are affected worldwide, including New Jersey in the United States. The defect allows a bushing to detach from the screw shaft after a longitudinal fracture. Healthcare providers and patients should stop using the device immediately and follow the manufacturer’s recall instructions. Notification was sent by,
Waldemar Link recalled 1 unit of Endo-Model Replacement Plateau implant component distributed worldwide, including New Jersey. The defect involves a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. Patients and healthcare providers should stop using the device immediately and follow the manufacturer’s recall instructions.
Waldemar Link GmbH & Co. KG recalls 4 Endo-Model Replacement Plateau units worldwide, including the US state of New Jersey. A longitudinal fracture can detach the bushing from the screw shaft. Stop using the device and follow the manufacturer’s recall instructions.
Waldemar Link GmbH & Co. KG recalls 8 units of Endo-Model Replacement Plateau worldwide after a reported risk that a bushing could detach from the screw shaft due to a longitudinal fracture. The recall also covers US distribution in New Jersey. Health authorities have classified the risk as high. Patients and healthcare providers should stop using the device immediately and follow recall guidance.