Jjgc Industria E Comercio De Materials Dentarios Sa Av Juscelino Kubitschek De Oliveira Curitiba Brazil GM Helix Acqua Implant 3.5x10, Article No. 140.944 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Brand
Jjgc Industria E Comercio De Materials Dentarios Sa Av Juscelino Kubitschek De Oliveira Curitiba Brazil
Lot Codes / Batch Numbers
UDI 7899878024897 Lots GNW15 and GRE82
Products Sold
UDI 7899878024897 Lots GNW15 and GRE82
Jjgc Industria E Comercio De Materials Dentarios Sa Av Juscelino Kubitschek De Oliveira Curitiba Brazil is recalling GM Helix Acqua Implant 3.5x10, Article No. 140.944 due to 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 indicatio. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026