Instradent USA, Inc. recalls NEODENT CM Intraoral Scanbody, Article Number: 108.139

Recall date

March 13, 2017

Source

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

Recall number

Z-1831-2017

FDA classification

Class II

Brand / firm

Instradent USA, Inc.

Sold / distributed

Distributed to the states of: NJ, TX, NV, CA, PA, AZ, and IL.

Why it was recalled

During internal testing, Neodent determined that the body diameter (3.8mm) of the Neodent 108.139 CM Exact Intraoral Scan body is not compatible with the platform diameter of CM Implants when the implant is intraosseoussly (subcrestally) positioned.

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

What was recalled

NEODENT CM Intraoral Scanbody, Article Number: 108.139