FDA Device recall Z-0203-2022
GM Helix Acqua Implant 3.5x10, Article No. 140.944
- FDA Device
- Class II
- terminated
- Published 2021-11-10
On 2021-11-10 the FDA classified a Class II recall of GM Helix Acqua Implant 3.5x10, Article No. 140.944 by Jjgc Industria E Comercio De Materials Dentarios, citing 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 (10m….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0203-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-10-11 |
| Published | 2021-11-10 |
| Last updated | 2026-09-13 11:56 UTC |
| Company | Jjgc Industria E Comercio De Materials Dentarios |
| Distribution | US |
Product
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Reason
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.
Identifiers
| code_info | UDI 7899878024897 Lots GNW15 and GRE82 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:56 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0203-2022%22
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