# FDA recall Z-0203-2022

> **Jjgc Industria E Comercio De Materials Dentarios Sa** · Class II · device recall initiated 2021-10-11.

## Product

GM Helix Acqua Implant 3.5x10, Article No. 140.944

## Reason for recall

3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-0203-2022
- **Recalling firm:** Jjgc Industria E Comercio De Materials Dentarios Sa
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2021-10-11
- **Report date:** 2021-11-10
- **Termination date:** 2024-01-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Curitiba, N/A, Brazil

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0203-2022

## Citation

> AI Analytics. FDA recall Z-0203-2022. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-0203-2022. Source: US FDA. Licensed CC0.

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