Countersink

How Is HWW Classified?

Countersink is FDA product code HWW, Class 1, 21 CFR 888.4540.

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 17 recalls under this product code since 2012. None was by a company in China. The root cause the FDA records most often is Component design/selection (1).

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