Recall Z-1485-2018— Keystone Dental Inc
Class II · Terminated
Class II FDA medical device recall by Keystone Dental Inc, initiated 2018-03-13, terminated 2018-07-23. It names one FDA 510(k) clearance: K101545. Product: 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..
- Recalling firm
- Keystone Dental Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-13
- Terminated
- 2018-07-23
- Firm location
- Burlington, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.