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.
The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.
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: Letter
Get instant alerts for Health & Personal Care recalls
Be the first to know. Free instant alerts to your inbox.
The Endo-Model Replacement Plateau is an orthopedic implant component used in surgical procedures. It is intended to integrate with other implant parts to restore function.
If the plateau screw bushing detaches from the screw shaft due to a longitudinal fracture, the implant could lose stability and function.
This recall is not described as part of a broader industry pattern in the provided data.
The recall indicates potential implant failure risk. No injuries have been reported, and the recall is active. Patients with this component should consult their surgeon.
Identifiers appear on device labeling, packaging, and recall notification letters.
No specific timeline provided for replacement or refunds.
Keep recall notices, medical records, device labels, and all correspondence with the manufacturer and healthcare providers.
Model numbers in recall: Item Number 15-0027/12; UDI-DI 04026575431960; Serial/Lot Number 2549036. Distribution: Worldwide, including US NJ and the countries Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Quantity: 1 unit.
No injuries or incidents have been reported.
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 recalled 1 unit of Endo-Model Replacement Plateau worldwide, including the United States in New Jersey. The device could detach its bushing from the screw shaft because of a longitudinal fracture. Clinicians and patients should stop using the device and await manufacturer 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.
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,