GM Helix Acqua Implant 3 — Class II medical device recall Z-0203-2022
Terminated recall by Jjgc Industria E Comercio De Materials Dentarios Sa, reported 2021-11-10, distributed nationwide. 3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low an
| Recall number | Z-0203-2022 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Jjgc Industria E Comercio De Materials Dentarios Sa, Curitiba, N/A, Brazil |
| Recall initiated | 2021-10-11 |
| Classified | 2021-11-04 |
| Reported by FDA | 2021-11-10 |
| Terminated | 2024-01-16 |
| Distributed | Nationwide (US) |
| Quantity | 567 |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 07899878024897 |
| Lot numbers | GNW15, GRE82 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0203-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.