---
title: "Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N — FDA record Z-0920-2025 | Is It on Recall"
description: "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 drill"
url: https://isitonrecall.com/recall/fda-device-z-0920-2025-implant-epikut-s-plus-cm-16-degrees-4-5-x-18-0-mm-ref-ilm-4518n/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA device enforcement

# Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N — FDA record Z-0920-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Sep 1, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Implant Epikut S Plus CM 16-Degrees 4,5 X 18,0 mm, REF: ILM 4518N
- **Reason**: 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.
- **Classification**: Class II
- **Recalling firm**: SIN SISTEMA DE IMPLANTE NACIONAL S.A
- **Quantity**: 123 (US 98, OUS 25)
- **Agency-reported status**: Ongoing
- **Source record identifier**: Z-0920-2025

[Open the official record](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0920-2025%22)

[What the recall classes mean](https://isitonrecall.com/guides/recall-classes/). Classification is an agency assessment, not individual medical advice.

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | UDI-DI: 07899995273437, Lot: X010469757, Expiration: 2028/01 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Distribution

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

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

- [California](https://isitonrecall.com/state/california/)
- [Colorado](https://isitonrecall.com/state/colorado/)
- [Florida](https://isitonrecall.com/state/florida/)
- [Idaho](https://isitonrecall.com/state/idaho/)
- [Illinois](https://isitonrecall.com/state/illinois/)
- [Kentucky](https://isitonrecall.com/state/kentucky/)
- [New Jersey](https://isitonrecall.com/state/new-jersey/)
- [New York](https://isitonrecall.com/state/new-york/)
- [Ohio](https://isitonrecall.com/state/ohio/)
- [Texas](https://isitonrecall.com/state/texas/)

## Dates in the source

- **Report date**: Jan 22, 2025
- **Recall initiation date**: Sep 1, 2024
- **Center classification date**: Jan 15, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Read the official notice for the action that applies to your exact product.

[Read the current instructions](https://api.fda.gov/device/enforcement.json?search=recall_number%3A%22Z-0920-2025%22)

## Related records

[Medical devices records](https://isitonrecall.com/category/medical-devices/) [SIN SISTEMA DE IMPLANTE NACIONAL S.A records](https://isitonrecall.com/brand/sin-sistema-de-implante-nacional-s-a/)