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Jjgc Industria E Comercio De Materials Dentarios Sa recalls GM Helix Acqua Implant 3.5x10, Article No. 140.944
Recalled November 10, 2021 · FDA recall Z-0203-2022 · Jjgc Industria E Comercio De Materials Dentarios Sa
Hazard
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. · FDA Class II
Units
567 (US)
Sold at
US Nationwide distribution.
Description
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.
Product
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Manufacturer(s)
Jjgc Industria E Comercio De Materials Dentarios Sa
Made in
Brazil
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →