Jjgc Industria E Comercio De Materials Dentarios Sa: Medical Device Recall in 2021 - (Recall #: Z-0203-2022)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

GM Helix Acqua Implant 3.5x10, Article No. 140.944

Product Classification:

Class II

Date Initiated: October 11, 2021

Date Posted: November 10, 2021

Recall Number: Z-0203-2022

Event ID: 88917

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.

Status: Terminated

Product Quantity: 567 (US)

Code Information:

UDI 7899878024897 Lots GNW15 and GRE82

Distribution Pattern:

US Nationwide distribution.

Voluntary or Mandated:

Voluntary: Firm initiated