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.
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 component used in orthopedic implant systems. The device is intended to secure a plateau screw in the implant construct.
A longitudinal fracture could cause the bushing to detach from the screw shaft, potentially compromising implant integrity.
This recall is not part of a broader industry pattern at this time.
Immediate halt in use is required. No injuries reported, but the risk could affect implant stability.
UDI labels on the device packaging; documentation from healthcare providers; FDA recall page linked in the notice
Remedy and replacement/reimbursement details will be provided via manufacturer communication in the recall process
Document recall notice, serial numbers, and any correspondence with the manufacturer or healthcare provider
Product: Endo-Model Replacement Plateau. Item Number: 15-0027/11. UDI-DI: 04026575431953. Serial/Lot Numbers: 2549126, 2549127. Quantity: 2 units. Distribution: Worldwide with US nationwide distribution in New Jersey. Countries: Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia. Manufacturer: Waldemar Link GmbH & Co. KG.
No injuries or incidents have been reported in the announced data.
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