FDA Medical Device Recalls (openFDA)
Keystone Dental Inc: Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
- Recall number
- Z-1485-2018
- Recalling firm
- Keystone Dental Inc
- Product
- Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket
- Status
- Terminated
- Initiated
- 2018-03-13
- Posted
- not on file
- Terminated
- 2018-07-23
- 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.
- Root cause
- Error in labeling
- 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.
- Quantity
- 19
- Distribution
- USA (nationwide) Distribution and Internationally to Turkey.
- Lot, serial or model codes
- lot #s 38177 38330 38421
- 510(k) numbers
- ["K101545"]
- PMA numbers
- not on file
- Product code
- DZE
- Firm FEI
- 3005990499
- Firm city
- Burlington
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28