Injector, Vertebroplasty (Does Not Contain Cement)

What Is It?

Intended for injection of vertebroplasty bone cement for the fixation of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty procedures. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).

What Is FDA Product Code OAR?

Injector, Vertebroplasty (Does Not Contain Cement) is FDA product code OAR, Class 1, 21 CFR 888.4200.

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 Do the Recalls Say?

The FDA has recorded 26 recalls under this product code since 2012. None was by a company in China. The root causes the FDA records most often are Labeling design (17), Environmental control (2) and Labeling Change Control (2).

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