FDA Device recall Z-1485-2018
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extra…
- FDA Device
- Class II
- terminated
- Published 2018-05-02
On 2018-05-02 the FDA classified a Class II recall of Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extra… by Keystone Dental, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1485-2018 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-03-13 |
| Published | 2018-05-02 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Keystone Dental |
| Distribution | US |
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.
Identifiers
| code_info | lot #s 38177 38330 38421 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1485-2018%22
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