SIN SISTEMA DE IMPLANTE NACIONAL S.A recalls Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N

Recall date

September 1, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0920-2025

FDA classification

Class II

Brand / firm

SIN SISTEMA DE IMPLANTE NACIONAL S.A

Sold / distributed

US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N