Z-0203-2022Class II

GM Helix Acqua Implant 3.5x10, Article No. 140.944

Name: Z-0203-2022 GM Helix Acqua Implant 3.5x10, Article No. 140.944
Creator: Jjgc Industria E Comercio De Materials Dentarios Sa
Published: 2021-10-11
License: https://open.fda.gov/license/

JJGC Industria e Comercio de Materiais Dentarios SA / initiated 2021-10-11 / Terminated / root cause: labeling and UDI

FDA source

Jjgc Industria E Comercio De Materials Dentarios Sa began a recall of GM Helix Acqua Implant 3.5x10, Article No. 140.944 on 2021-10-11. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0203-2022
Classification: Class II
Status: Terminated
Initiated: 2021-10-11
Posted: 2021-11-04
Terminated: 2024-01-16
Recalling firm: JJGC Industria e Comercio de Materiais Dentarios SA
Product: GM Helix Acqua Implant 3.5x10, Article No. 140.944
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: labeling and UDI
FDA root cause: Under Investigation by 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.
Quantity in commerce: 567 (US)
Distribution: US Nationwide distribution.
Product codes and lots: UDI 7899878024897 Lots GNW15 and GRE82

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0203-2022
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0203-2022	Class II	Terminated	Voluntary: Firm initiated	2021-11-10	2021-11-04

Product code DZE

K163194Class IINeodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. / cleared 2017-07-14

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)