FDA Recall
Terminated
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
Recall: Z-1485-2018
·
Initiated March 13, 2018
Recall
- Recall Number
- Z-1485-2018
- Event Number
- 79749
- Firm
- Keystone Dental Inc
- FEI Number
- 3005990499
- Product Code
- DZE
- Status
- Terminated
- Root Cause
- Error in labeling
- Initiated
- March 13, 2018
- Terminated
- July 23, 2018
- Address
- 154 Middlesex Tpke, Burlington, MA, 01803-4403
Description
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
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.
Action
Notification was mailed to all impacted customers on March 13, 2018, via overnight Federal Ex-press. Customer Relations will contact the customers via phone to ensure the customers received the notification, instructions, and replacement grommets. Customer Relations Reply Forms are being used to document the communication. For further questions, please call (866) 902-9272.
Distribution
USA (nationwide) Distribution and Internationally to Turkey.
Quantity
19