Filler, Bone Void, Calcium Compound

What Is FDA Product Code MQV?

Filler, Bone Void, Calcium Compound is FDA product code MQV, Class 2, 21 CFR 888.3045.

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. Chinese applicants hold 1 clearance under this code; the FDA took 361 days from receipt to decision.

What Has Gone Wrong With It?

The FDA has recorded 120 recalls under this product code since 2005. None was by a company in China. The root causes the FDA records most often are Vendor change control (13), Process control (8) and Employee error (6).

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