GM Helix Acqua Implant 3 recalled over labeling errors

Recall date

October 11, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Jjgc Industria E Comercio De Materials Dentarios Sa recalls GM Helix Acqua Implant 3.5x10, Article No. 140.944

Recall number

Z-0203-2022

FDA classification

Class II

Brand / firm

Jjgc Industria E Comercio De Materials Dentarios Sa

Sold / distributed

US Nationwide distribution.

Why it was 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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

GM Helix Acqua Implant 3.5x10, Article No. 140.944