Z-1485-2018 Class II Terminated

Recalled by Keystone Dental Inc — Burlington, MA

Recall Details

Product Type
Devices
Report Date
May 2, 2018
Initiation Date
March 13, 2018
Termination Date
July 23, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
19

Product Description

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 Pattern

USA (nationwide) Distribution and Internationally to Turkey.

Code Information

lot #s 38177 38330 38421