Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
GM Helix Acqua Implant 3.5x10 Recalled by Jjgc Industria E Comercio De Materials Dentarios Sa Due to Mislabeling
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Jjgc Industria E Comercio De Materials Dentarios Sa directly.
Affected Products
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Quantity: 567 (US)
Why Was This Recalled?
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.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Jjgc Industria E Comercio De Materials Dentarios Sa
Jjgc Industria E Comercio De Materials Dentarios Sa has 2 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report