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.
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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The Endo-Model Replacement Plateau is a spinal fixation implant component. It is used in surgeries to stabilize the spine.
A longitudinal fracture could cause the bushing to detach from the screw shaft, potentially compromising fixation.
This recall is not identified as part of a broader industry pattern in the provided data.
Implant component failure could necessitate surgical intervention or revision, with patient safety implications.
UDI labels on the device packaging and accompanying documentation
No remediation timeline provided; follow manufacturer instructions via recall notice
Document serial numbers, dates, communications with manufacturer, and any adverse events
Brand: Waldemar Link GmbH & Co. KG. Product: Endo-Model Replacement Plateau. Item Number: 15-8521/15. UDI-DI: 04026575383283. Serial/Lot Numbers: 250805/0020, 250805/0021, 250805/0023, 250805/0024. Quantity: 4 units. Sold Worldwide with NJ distribution in the US and in Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Recall Date: 2026-01-12. Status: Active.
No injuries or incidents have been reported in the provided data.
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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,