Endo-Model SL Connection Component incl. PE-Plateau recall (Waldemar Link GmbH & Co. KG (Mfg Site))

Medical deviceClass IIOngoing

Summary: Waldemar Link GmbH & Co. KG (Mfg Site) is recalling Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;. Reason: The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture.

What is being recalled

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07;

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

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. (states named: New Jersey)

How to tell if yours is affected

Item Number: 16-2840/07; UDI-DI: 04026575359257; Serial/Lot Number: 250925/0480 , 250925/0481, 250925/0482, 250925/0483, 250925/0484, 250925/0486, 250925/0489 , 250925/0491, 250925/0492, 250925/0494, 250925/0503, 250925/0504, 250925/0345 , 250925/0346, 250925/0349, 250925/0350, 250925/0351, 250925/0352, 250925/0356 , 250925/0369, 250925/0501, 250925/0365, 250925/0368, 250925/0490, 250925/0488 , 250925/0479, 250925/0495, 250925/0500, 250925/0496, 250925/0499, 250925/0367;

What to do

Check the model, lot or serial numbers above against your device. If yours is affected, contact the manufacturer or your healthcare provider before you stop using a device you rely on.

Recall facts

More recalls from Waldemar Link GmbH & Co. KG (Mfg Site) · all medical device recalls · recalls from January 2026

Official FDA record