FDA-Device2025-01-22Class II
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
SIN SISTEMA DE IMPLANTE NACIONAL S.A
Hazard
Dental implant box incorrectly labels the diameter as 4,5 X 18,0 mm, but the internal label correctly labels the diameter as 4,0 X 18,0 mm; if the dentist drills the bone with the larger diameter stated on the box, the smaller diameter implant, will become loose and will not fit, which may necessitate an additional surgery.
Sold states
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Affected count
123 (US 98, OUS 25)
Manufactured in
Jardim Analia Franco, Rua Soldador Ocimar Guimaraes da Silva 421, Sao Paulo, Brazil
Products
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0920-2025Don't want to check this manually?
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