FDAClass IIMay 2, 2018

Genesis Surgical Cassette Tapered Implants are intended recall

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

Why was Genesis Surgical Cassette Tapered Implants are intended 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

lot #s 38177 38330 38421

Product
Genesis Surgical Cassette Tapered Implants are intended for placement following natural tooth loss or for immediate placement into an extraction…
Recalling firm
Keystone Dental Inc
Quantity
19
Distribution
USA (nationwide) Distribution and Internationally to Turkey.
Recall date
May 2, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls