FDA-Device2026-03-18Class II
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
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
4 units (all OUS)
Manufactured in
Ost Str. 4-10, N/A, Norderstedt, N/A, Germany
Products
Endo-Model Replacement Plateau; Item Number: 15-8030/12;
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1517-2026Original summary
Endo-Model Replacement Plateau; Item Number: 15-8030/12; 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: 15-8030/12; UDI-DI: 04026575048151; Serial/Lot Number: 250721/0194, 250721/0212, 250721/0211, 250721/0209; 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: 4 units (all OUS)
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