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

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.

Details from the source

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. Quantity: 123 (US 98, OUS 25) Lot/code info: UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01

UPC codes

07899995273437

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.