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,
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 an implant component used in surgical procedures. The recall centers on a mechanical defect that could compromise implant integrity.
A longitudinal fracture can cause the plateau screw bushing to detach from the screw shaft, risking device failure.
This recall is not described as part of a broader industry pattern in the notice.
Affected patients may require medical evaluation and potential corrective actions. The notice specifies immediate cessation of use.
On device packaging and accompanying documentation; recall letter; FDA recall page
Not specified in the recall notice
Keep recall letter, device labels, serial numbers, and all communications with providers and the manufacturer
Model numbers: Item Number 15-0027/15; UDI-DI 04026575432127; Serial/Lot Number 2549190. Sold worldwide to healthcare providers, including US NJ and a list of countries. When sold: Unknown. Price: Unknown.
No injuries or incidents have been reported.
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