FDA-Device2021-11-10Class II
GM Helix Acqua Implant 3.5x10, Article No. 140.944
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.
Sold states
US Nationwide distribution.
Affected count
567 (US)
Manufactured in
Av Juscelino Kubitschek De Oliveira, N/A, Curitiba, N/A, Brazil
Products
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0203-2022Don't want to check this manually?
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