FDA recall Z-0920-2025

SIN SISTEMA DE IMPLANTE NACIONAL S.A · Class II · device

Product

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

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.

Key facts

Status
Ongoing
Initiation date
2024-09-01
Report date
2025-01-22
Voluntary/Mandated
Voluntary: Firm initiated
Location
Sao Paulo, Brazil

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0920-2025