The U.S. Food and Drug Administration (FDA) has sent a letter to Johnson & Johnson/DePuy warning them that several of their hip, knee and joint replacement devices were "improperly marketed" which has caused Johnson & Johnson/DePuy to refrain from marketing some of these devices.

A warning letter sent  in December to J&J /DePuy has noted that DePuy made 14 types of devices which did not receive pre-market clearance or approval by FDA. The information provided in the letter resulted from inspection(s) which occurred from May 10 to June 7, 2011. 

The company had indicated "it believed the devices were custom-made, requested by surgeons to match an individual patient’s anatomy and exempt from the approval process." According to a DePuy spokesperson quoted in media, “Custom medical devices have been exempt from pre-market review since 1976." It appears FDA’s position is just because devices are tailored to an individual’s anatomy doesn’t make the device unavailable to other doctors, nor does it preclude the FDA approval process.

In the warning letter, FDA has also cited inadequate product non-conformance and complaint review processes by DePuy and quality problems with some of the devices. 

This is yet one more major problem and headache for DePuy and Johnson & Johnson as the companies have suffered from poor quality concerns and numerous recalls, including the DePuy ASR metal on metal hips which are failing and causing affected patients to have high metal concentrations in their blood (chromium and cobalt), pain and swelling, and revision surgeries to remove and replace the defective ASR hip implants.

Additionally, the DePuy Pinnacle metal on metal hip implants may also be similarly defective, but Johnson & Johnson and DePuy have not recalled those hips, arguing those hip implants are not defective.