Device product
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
Z-1485-2018
Product summary
- Event
- Event 79749
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19
- Official record key
device-enforcement:Z-1485-2018
Official wording
Reason: The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
Code information: lot #s 38177 38330 38421
Distribution pattern: USA (nationwide) Distribution and Internationally to Turkey.
Derived failure modes
-
Unknown
The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.