Keystone Dental Inc recalls Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate pla…

Recall date

March 13, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1485-2018

FDA classification

Class II

Brand / firm

Keystone Dental Inc

Sold / distributed

USA (nationwide) Distribution and Internationally to Turkey.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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