Medical Device Recall: Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
SIN SISTEMA DE IMPLANTE NACIONAL S.A · September 1, 2024
Reason for Recall
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.
Distribution
US distribution to states of: KY, CO, CA, NY, ID, NJ, FL, TX, KY, IL, OH; AND OUS (foreign) country of Brazil.
States Affected
CA, CO, FL, ID, IL, KY, NJ, NY, OH, TX
Quantity Affected
123 (US 98, OUS 25)
Source: FDA (openFDA Device Enforcement)
Recall number: Z-0920-2025
Status: ongoing
SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.