Device product
Neodent Easypack Helix GM Acqua 3.5X13/Smart 4.5X2.5 Article Number: 138.107
Z-0513-2022
Product summary
- Event
- Event 89321
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-0513-2022
Official wording
Reason: Mislabeled: Carton box item 138.089- Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 has an implant with measure of 3.5x13mm; and Carton Box (138.107- Easypack Helix GM Acqua has a 3.5x8mm implant instead of a 3.5x 13mm implant
Code information: Lot GNV20: UDI:7899878052906
Distribution pattern: US Nationwide Distribution in the states of FL, IL, OH
Derived failure modes
-
Labeling or packaging
Mislabeled