Home / Recalls / Jjgc Industria E Comercio De Materials Dentarios Sa / Z-0203-2022

Z-0203-2022 Class II Terminated

Recalled by Jjgc Industria E Comercio De Materials Dentarios Sa — Curitiba, N/A

Recall Details

Product Type: Devices
Report Date: November 10, 2021
Initiation Date: October 11, 2021
Termination Date: January 16, 2024
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 567 (US)

Product Description

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 Pattern

US Nationwide distribution.

Code Information

UDI 7899878024897 Lots GNW15 and GRE82