Shoulder Prosthesis, Reverse Configuration

What Is This Device?

Intended to be used to relieve pain and to replace the glenoid and humeral side of the shoulder joint in order to restore mobility in a grossly rotator cuff deficient joint with severe arthropathy or a previous joint replacement with a grossly rotator cuff deficient joint.

What Is FDA Product Code PHX?

Shoulder Prosthesis, Reverse Configuration is FDA product code PHX, Class 2, 21 CFR 888.3660.

How Does It Reach the US Market?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. No clearance under this code names a Chinese applicant. A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

What Has Gone Wrong With It?

The FDA has recorded 68 recalls under this product code since 2015. None was by a company in China. The root causes the FDA records most often are Nonconforming Material/Component (12), Equipment maintenance (8) and Process control (8).

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