FDA recall Z-1485-2018

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.

Distribution

USA (nationwide) Distribution and Internationally to Turkey.

Key facts

Status

Terminated

Initiation date

2018-03-13

Report date

2018-05-02

Termination date

2018-07-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Burlington, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1485-2018