Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0203-2022 — GM Helix Acqua Implant 3.5x10, Article No. 140.944

U.S. FDA — Device Enforcement · Brazil · 2021-10-11 · Class II

AI-assisted, human-edited — this page is drafted with AI from public-source data, then reviewed before publication. How we use AI →
Agency
U.S. FDA — Device Enforcement
Recall identifier
Z-0203-2022
Date of alert
2021-10-11
Country / jurisdiction
Brazil
Risk level
Class II
Risk type
recall
Brand
Jjgc Industria E Comercio De Materials Dentarios Sa
Product category
device
Product type
Devices
Barcode (EAN/GTIN)
7899878024897
Reported risk: 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.
Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

Related

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.