Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented

What Is FDA Product Code LPH?

Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented is FDA product code LPH, Class 2, 21 CFR 888.3358.

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 311 days from receipt to decision.

What Do the Recalls Say?

The FDA has recorded 297 recalls under this product code since 2003. None was by a company in China. The root causes the FDA records most often are Packaging (67), Process control (28) and Employee error (25).

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