GM Helix Acqua Implant 3.5x10, Article No. 140.944 recallZ-0203-2022 · Jjgc Industria E Comercio De Materials Dentarios Sa · initiated Oct 11, 2021
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Jjgc Industria E Comercio De Materials Dentarios Sa or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
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.
Recall details
- Recall number
- Z-0203-2022
- Status
- Terminated
- Initiated by the company
- Oct 11, 2021
- Recalling firm
- Jjgc Industria E Comercio De Materials Dentarios Sa
- Quantity
- 567 (US)
- Product code
- DZE
- FDA submissions
- K163194
- Distribution
- US Nationwide distribution.
Product description
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Code information (models, lots, serial numbers)
UDI 7899878024897 Lots GNW15 and GRE82
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Neodent 140.944JJGC Indústria e Comércio de Materiais Dentários S/A. · IMPLANT, ENDOSSEOUS, ROOT-FORM1 recall5,373 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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