Device product
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Z-0203-2022
Product summary
- Event
- Event 88917
- Status
- Terminated
- Classification
- Class II
- Quantity
- 567 (US)
- Official record key
device-enforcement:Z-0203-2022
Official wording
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.
Code information: UDI 7899878024897 Lots GNW15 and GRE82
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
mislabeled