Z-1485-2018 Class II Terminated
FDA device recall Z-1485-2018 was initiated by Keystone Dental Inc on March 13, 2018 and is designated Class II. Reason for recall: 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. The recall status is terminated (terminated July 23, 2018). Affected quantity: 19.
Recall Details
- Product Type
- Devices
- Report Date
- May 2, 2018
- Initiation Date
- March 13, 2018
- Termination Date
- July 23, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 19
Product Description
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
Reason for Recall
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.
Distribution Pattern
USA (nationwide) Distribution and Internationally to Turkey.
Code Information
lot #s 38177 38330 38421