Z-1485-2018Class II

Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for...

Name: Z-1485-2018 Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for...
Creator: Keystone Dental Inc
Published: 2018-03-13
License: https://open.fda.gov/license/

Keystone Dental Inc. / initiated 2018-03-13 / Terminated / root cause: labeling and UDI

FDA source

Keystone Dental Inc began a recall of Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket on 2018-03-13. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1485-2018
Classification: Class II
Status: Terminated
Initiated: 2018-03-13
Posted: 2018-04-24
Terminated: 2018-07-23
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
Product code: DZE Implant, Endosseous, Root-Form
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.
Root cause tag: labeling and UDI
FDA 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 in commerce: 19
Distribution: USA (nationwide) Distribution and Internationally to Turkey.
Product codes and lots: lot #s 38177 38330 38421

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1485-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1485-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-02	2018-04-24

Product code DZE

K101545Class IIGenesis Implant SystemKeystone Dental / cleared 2010-10-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)