Prosthesis, Breast, External, Used With Adhesive

How Is KCZ Classified?

Prosthesis, Breast, External, Used With Adhesive is FDA product code KCZ, Class 1, 21 CFR 878.3800.

How Does It Reach the US Market?

It is exempt from premarket notification: the manufacturer registers its establishment and lists the device, and no 510(k) is needed before it is sold in the United States.

What Has Gone Wrong With It?

The FDA has recorded 1 recall under this product code since 2019. None was by a company in China. The root cause the FDA records most often is Packaging process control (1).

A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.