Healthcare giant Johnson & Johnson has announced a voluntary recall of two hip-replacement systems due to a higher rate of revision surgeries required by patients. The recall adds to the company's growing list of quality issues and comes just days after the company was warned by the FDA that is improperly marketing two other products.
DePuy Orthopaedics Inc., the orthopaedics unit of Johnson & Johnson, said that the recalled devices are the ASR XL Acetabular System, which is the cup portion of a replacement hip joint, and the ASR Hip Resurfacing System, a partial hip replacement that involves placing a metal cap on the ball of the hip bone or femur.
The ASR Hip Resurfacing system was introduced in 2003 and is only approved for use outside the U.S. The ASR XL Acetabular system was first launched in 2004 and has been available worldwide.
DePuy said it initiated the recall based on new, unpublished data from the National Joint Registry of England and Wales which showed that more people than expected who received the ASR Hip System experienced pain and other symptoms, leading to a second hip replacement surgery, called a revision surgery.
Specifically, the data shows that five years after implantation, about 12% of patients who had received the ASR resurfacing device and 13% of patients who had received the ASR total hip replacement needed to have a revision surgery.
DePuy noted that very few of these hip systems remain on the market after the company decided to discontinue sales last year due to declining demand and to focus on new products.
The company advised patients with an ASR device to visit their surgeons for evaluation of device performance and recommended yearly monitoring to ensure the device is functioning well, even in the absence of symptoms. The company said it intends to cover reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall.
The recall comes just days after the FDA issued a warning letter to DePuy for selling hip and other joint products without the agency's approval. The FDA said in its letter dated August 19 that the company has been selling its TruMatch Personalized Solutions System, which makes artificial knee products, and the Corail Hip System without marketing clearance and in violation of the Federal Food, Drug, and Cosmetic Act. The FDA has given DePuy 15 days to correct the violations.
Johnson & Johnson has come under intense scrutiny by the FDA and federal prosecutors over the past year. On Monday, the company's Vision Care Inc. unit reportedly issued a voluntary recall for about 100,000 boxes of "1 Day Acuvue TruEye" contact lenses sold in Asia and Europe, citing a manufacturing problem.
Johnson & Johnson's McNeil Consumer Healthcare unit has issued several recalls of over-the-counter drugs since 2008 and has received warning letters related to manufacturing lapses at its factories in the U.S.
In July 2010, the company widened its recall of over-the-counter or OTC products announced earlier in the year. The company recalled medicines like Benadryl, Motrin and Tylenol, which were missed out from its original product recall in January. Operations at the company's Fort Washington plant in Pennsylvania were suspended in connection with the recall of infants' and children's liquid OTC products manufactured there.
In Friday's regular trading, JNJ is trading at $57.35, up $0.09 or 0.16% on a volume of 22,920 shares. The stock has been trading in a range of $56.86-$66.20 in the past 52 weeks.
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by RTT Staff Writer
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