Jjgc Industria E Comercio De Materials Dentarios Sa Recall 88917
Description: GM Helix Acqua Implant 3.5x10, Article No. 140.944
Jjgc Industria E Comercio De Materials Dentarios Sa Recall 88917 Information
| Status | Terminated |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-0203-2022 |
| Event ID | 88917 |
| Event Description | GM Helix Acqua Implant 3.5x10, Article No. 140.944 |
| Product Type | Devices |
| Distribution | US Nationwide distribution. |
| Quantity | 567 (US) |
| Recall 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. |
| Device Classification | 20211110 |
| Device Code Info | UDI 7899878024897 Lots GNW15 and GRE82 |
| Center Classification Date | 20211104 |
| Recall Initiation Date | 20211011 |
| Recalling Firm | Jjgc Industria E Comercio De Materials Dentarios Sa |
| Initial Notification | Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit |
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