SIN SISTEMA DE IMPLANTE NACIONAL S.A: Medical Device Recall in 2025 - (Recall #: Z-0920-2025)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2025.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: September 1, 2024

Date Posted: January 22, 2025

Recall Number: Z-0920-2025

Event ID: 95983

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.

Status: Ongoing

Product Quantity: 123 (US 98, OUS 25)

Code Information:

UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated