Waldemar Link recalled 3 Endo-Model Replacement Plateau implants distributed worldwide, including New Jersey. The devices carry a risk that a bushing could detach from the plateau screw shaft due to a longitudinal fracture. Healthcare providers and patients should stop using the device immediately and follow manufacturer 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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Endo-Model Replacement Plateau is a component used in orthopedic implants. It is used by surgeons under medical protocols.
A longitudinal fracture could cause the bushing to detach from the screw shaft, potentially affecting implant stability.
This recall is not part of a broader industry pattern at this time.
Hospitals and patients may face delays in care and additional follow-up for implant safety.
Check device packaging and labeling for item number, UDI, and serial numbers
Not specified in public notices
Keep copies of the recall notice, labeling, serial numbers, and all correspondence with the manufacturer.
Model numbers: Item Number 15-0027/16; UDI-DI 04026575432134; Serial/Lot Numbers: 2550412, 2550413, 2549228; Sold worldwide including US NJ and the countries Belarus, Canada, Switzerland, Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia; Quantity: 3 units; Price: Unknown; When sold: Unknown
No injuries or incidents have been reported.
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