# FDA recall Z-0920-2025

> **SIN SISTEMA DE IMPLANTE NACIONAL S.A** · Class II · device recall initiated 2024-09-01.

## 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

- **Recall number:** Z-0920-2025
- **Recalling firm:** SIN SISTEMA DE IMPLANTE NACIONAL S.A
- **Classification:** Class II
- **Product type:** device
- **Status:** Ongoing
- **Initiation date:** 2024-09-01
- **Report date:** 2025-01-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Sao Paulo, Brazil

## Primary source

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

## Citation

> AI Analytics. FDA recall Z-0920-2025. Retrieved 2026-09-04 from https://api.ai-analytics.org/recall/Z-0920-2025. Source: US FDA. Licensed CC0.

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