FDA-Device2021-11-10Class II
GM Helix Acqua Implant 3.5x10, Article No. 140.944
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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