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SIN SISTEMA DE IMPLANTE NACIONAL S.A recalls Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Recalled January 22, 2025 · FDA recall Z-0920-2025 · 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. · FDA Class II
Units
123 (US 98, OUS 25)
Sold at
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
Description
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.
Product
Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
Manufacturer(s)
SIN SISTEMA DE IMPLANTE NACIONAL S.A
Made in
Brazil
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →