FDA recall Z-0203-2022

Jjgc Industria E Comercio De Materials Dentarios Sa · Class II · device

Product

GM Helix Acqua Implant 3.5x10, Article No. 140.944

Reason for recall

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.

Distribution

US Nationwide distribution.

Key facts

Status: Terminated
Initiation date: 2021-10-11
Report date: 2021-11-10
Termination date: 2024-01-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Curitiba, N/A, Brazil

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0203-2022