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Terminated

GM Helix Acqua Implant 3.5x10, Article No. 140.944

FDA Recall Z-0203-2022 · Posted None

Recalling FirmJjgc Industria E Comercio De Materials Dentarios Sa
Recall StatusTerminated
Product CodeDZE
Date Initiated2021-10-11
Date Terminated2024-01-16
Product Quantity567 (US)

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.

Firm Action

The firm initially contacted affected customers by phone on October 11, 2021. Customers were instructed to immediately stop using the product and to place all impacted product in quarantine. The firm then followed up with a confirmation letter sent by UPS on October 22, 2021. Customers were instructed to identify and segregate the affected units, open or closed, in their stock. Product is to be returned to the manufacturer.' If product has been installed and the patient reports an issue (such as numbness, pain, or other symptoms), please notify the distributor immediately to receive instructions on how to proceed.

Root Cause

Under Investigation by firm

Distribution Pattern

US Nationwide distribution.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017-07-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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