Device product
Neodent Easypack Helix GM Acqua 3.5X8/Smart 4.5X2.5 -intended for dental implant Item 138.089
Z-0512-2022
Product summary
- Event
- Event 89321
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7 pieces
- Official record key
device-enforcement:Z-0512-2022
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 GNV17 UDI: 7899878052722
Distribution pattern: US Nationwide Distribution in the states of FL, IL, OH
Derived failure modes
-
Labeling or packaging
Mislabeled