FDA-Device2026-03-18Class II

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

Waldemar Link GmbH & Co. KG (Mfg Site)

Hazard

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

Sold states

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.

Affected count

31 units (OUS only)

Manufactured in

Ost Str. 4-10, N/A, Norderstedt, N/A, Germany

Products

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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1514-2026

Original summary

Endo-Model SL Connection Component incl. PE-Plateau; Item Number: 16-2840/07; The potential for an implant with a plateau screw where the bushing could detach from the screw shaft due to a longitudinal fracture. 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; 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. Affected quantity: 31 units (OUS only)

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