FDA-Device2026-03-18Class II

Endo-Model Replacement Plateau; Item Number: 15-8521/09;

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

8 units (OUS only)

Manufactured in

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

Products

Endo-Model Replacement Plateau; Item Number: 15-8521/09;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1518-2026

Original summary

Endo-Model Replacement Plateau; Item Number: 15-8521/09; 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: 15-8521/09; UDI-DI: 04026575383238; Serial/Lot Number: 250728/0038, 250728/0039, 250728/0040, 250728/0041, 250728/0042, 250728/0043, 250728/0044, 250728/0045; 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: 8 units (OUS only)

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