Genesis Surgical Cassette Tapered Implants are intended for placement… — Class II medical device recall Z-1485-2018
Terminated recall by Keystone Dental Inc, reported 2018-05-02, distributed nationwide. The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble wit
| Recall number | Z-1485-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Keystone Dental Inc, Burlington, MA, United States |
| Recall initiated | 2018-03-13 |
| Classified | 2018-04-24 |
| Reported by FDA | 2018-05-02 |
| Terminated | 2018-07-23 |
| Distributed | Nationwide (US) |
| Countries outside the US | TR |
| Quantity | 19 |
| Lot numbers | 38177, 38330, 38421 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1485-2018. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.