medical Class II Updated 2021-11-10

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

Recalled Product

GM Helix Acqua Implant 3.5x10, Article No. 140.944


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: UDI 7899878024897 Lots GNW15 and GRE82
View official government recall

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