Keystone Dental Inc: Medical Device Recall in 2018 - (Recall #: Z-1485-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction socket

Product Classification:

Class II

Date Initiated: March 13, 2018

Date Posted: May 2, 2018

Recall Number: Z-1485-2018

Event ID: 79749

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.

Status: Terminated

Product Quantity: 19

Code Information:

lot #s 38177 38330 38421

Distribution Pattern:

USA (nationwide) Distribution and Internationally to Turkey.

Voluntary or Mandated:

Voluntary: Firm initiated