Endo-Model Replacement Plateau; Item Number: 15-0027/11; – The potential for an implant with a plateau screw where… – Waldemar Link GmbH & Co. KG (Mfg Site)

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Recall Category: Medical Device Recalls

Recalling Firm: Waldemar Link GmbH & Co. KG (Mfg Site)

Product: Endo-Model Replacement Plateau; Item Number: 15-0027/11;

Reason for Recall: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

Classification: Class II

Status: Ongoing

Report Date: 03/18/2026

Recall Initiation Date: 01/12/2026

Distribution: Worldwide – US Nationwide distribution in the state of NJ and the countries of Belarus, Canada, Switzerland , Colombia, Germany, Spain, United Kingdom, Hungary, India, Italy, Netherlands, Romania, Saudi Arabia.

Code Info: Item Number: 15-0027/11; UDI-DI: 04026575431953; Serial/Lot Number: 2549126, 2549127;

Product Quantity: 2 units (OUS only)

Recall Type: Voluntary: Firm initiated

Initial Firm Notification: Letter

Firm Location: Norderstedt, N/A, Germany

Recall Number: Z-1521-2026

Event ID: 98342

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