GM Helix Acqua Implant 3.5x10, Article No. 140.944
FDA Recall Notice
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0203-2022.
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.
Corrective Action (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0203-2022.
Recall terminated by FDA.
✅ What you should do
- Stop using the product if you own it.
- Check the model number, lot code, or sell-by date against the recall notice above.
- Contact Jjgc Industria E Comercio De Materials Dentarios Sa or the retailer where you bought it for a refund, replacement, or repair.
- For the most current official instructions, visit the FDA recall page.
- If you've been hurt by this product, report the incident to FDA.
Consumer Contact (per FDA)
Source: U.S. Food and Drug Administration (FDA) — official FDA notice for recall FDA-Z-0203-2022.
Jjgc Industria E Comercio De Materials Dentarios Sa
About the U.S. Food and Drug Administration
The FDA regulates drugs, medical devices, food, cosmetics, and tobacco. Adverse event reports and recall notices are the main public safety signal.
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If you had a reaction, found contamination, or experienced a labeling problem with this product, report it to the FDA. The agency uses consumer reports to track emerging safety signals and trigger recalls.
Jjgc Industria E Comercio De Materials Dentarios Sa Recall FAQ
Jjgc Industria E Comercio De Materials Dentarios Sa is the subject of a medical implants safety report: GM Helix Acqua Implant 3.5x10, Article No. 140.944. The notice was published on October 11, 2021 by the U.S. Food and Drug Administration (FDA). Approximately 567 units are potentially affected.