FDA-Device2026-03-18Class II

Endo-Model Replacement Plateau; Item Number: 15-8521/11;

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

7 units (OUS only)

Manufactured in

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

Products

Endo-Model Replacement Plateau; Item Number: 15-8521/11;

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1519-2026

Original summary

Endo-Model Replacement Plateau; Item Number: 15-8521/11; 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: 15-8521/11; UDI-DI: 04026575383245; Serial/Lot Number: 250728/2220, 250728/2222, 250728/2223, 250728/2224, 250728/2225, 250728/2226, 250728/2227; 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: 7 units (OUS only)

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