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 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.
Get instant alerts for recalls that affect you. Free forever.
Glenmark Pharmaceuticals recalled nearly 97,000 packs of Ondansetron Orally Disintegrating Tablets on December 30, 2025. Defective blister packs may not fully seal, leading to tablets falling out. Consumers should stop using the product immediately and contact healthcare providers.
Novo Nordisk recalled Wegovy (semaglutide) injections on December 19, 2025, after discovering hair in prefilled syringes. The contamination poses a serious hazard to consumers. The recall affects all units distributed nationwide.
Novo Nordisk recalled Wegovy (semaglutide) Injection on December 19, 2025, due to hair found in a prefilled syringe. The recall affects products distributed nationwide in the United States. Consumers should stop using the product immediately and contact their healthcare provider.
Zydus Pharmaceuticals recalled over 2,100 bottles of TraZODONE Hydrochloride Tablets on December 19, 2025. Some tablets have surface dents that may affect medication integrity. Consumers should stop using the product immediately and seek guidance from healthcare providers.
CareFusion 213, LLC recalled 106,400 units of ChloraPrep Triple Swabsticks on December 17, 2025. The recall occurred due to a lack of assurance of sterility. Consumers must stop using the product immediately and contact CareFusion for guidance.
Merck Sharp & Dohme LLC recalled 845 kits of Noxafil Powdermix on December 12, 2025. The recall follows the discovery of potential metal particulates in the product. Consumers should stop using the medication immediately and contact their healthcare provider for further guidance.
Merck Sharp & Dohme LLC recalled 3 single-dose kits of Emend (aprepitant) on December 12, 2025. The recall stems from the potential presence of metal particulates in the medication. Consumers should immediately stop using the product and contact their healthcare provider for guidance.
Beaver-Visitec International recalled five units of the OME6000U Laser and Endoscopy System on December 5, 2025. The recall stems from a manufacturing deviation where ferrites required for the USB cable were not installed. This omission poses a high electrical hazard risk to patients and healthcare providers.