Recall Z-0203-2022— Jjgc Industria E Comercio De Materials Dentarios Sa

Name: FDA recall Z-0203-2022
Creator: U.S. Food and Drug Administration
Published: 2021-10-11

Class II · Terminated

Class II FDA medical device recall by Jjgc Industria E Comercio De Materials Dentarios Sa, initiated 2021-10-11, terminated 2024-01-16. It names one FDA 510(k) clearance: K163194. Product: GM Helix Acqua Implant 3.5x10, Article No. 140.944. Reason: 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..

Recalling firm: Jjgc Industria E Comercio De Materials Dentarios Sa
Classification: Class II
Status: Terminated
Initiated: 2021-10-11
Terminated: 2024-01-16
Firm location: Curitiba, N/A, Brazil

510(k) clearances named in this recall

1 on FDA's record

K163194 — Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A.·cleared 2017-07-14

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.