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.
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
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Endo-Model Replacement Plateau is used in orthopedic implants as part of plate systems. Buyers seek stability and compatibility with screw shafts.
A longitudinal fracture could detach the bushing from the screw shaft, threatening implant stability.
This recall is not clearly stated as part of a broader industry pattern.
Immediate cessation of device use is required; patients may experience delays in treatment while navigating replacement options.
UDI and serial numbers on device packaging and official recall notices
Refunds/replacements depend on manufacturer guidance; expect weeks to months
Keep recall notices, serial numbers, and communications with healthcare providers
Item Number 15-8521/09. UDI-DI: 04026575383238. Serial/Lot Numbers: 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045. Sold worldwide with US NJ distribution. Manufacturer: Waldemar Link GmbH & Co. KG.
No specific injuries or incidents are described in the provided data. Hazard level is HIGH based on the potential risk.
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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 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.
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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,