Recall Z-0203-2022 ยท DZE Implant, Endosseous, Root-Form
Jjgc Industria E Comercio De Materials Dentarios Sa
GM Helix Acqua Implant 3.5x10, Article No. 140.944
| Date | Oct 11, 2021 |
| Status | Terminated |
| Reason | 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 | 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 instruct |
| Quantity | 567 (US) |
| Distribution | US Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K163194 | Neodent Implant System - GM Line Jjgc Industria E Comercio DE Materiais Dentarios S.A., Jul 14, 2017 |