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worldwide recall 23 articles

More government oversight credited for jump in medical device recalls

The number of medical device recalls has doubled in the past 10 years, according to a new report, a result of more government oversight and manufacturers doing a better job of halting sales of defective devices, officials say. Yearly recalls jumped from about 600 in 2003 to 1,200 in 2012, according to the report, which was prompted in 2011 by the Government Accountability Office (GAO). The largest rise was due to radiological devices, such as MRI and CT scanners, which have been found to register false positives and increase the risk of cancer. A fifth of the recalls in 2012 ... Read More

Johnson and Johnson to pay $2.5 billion to resolve thousands of ASR metal hip lawsuits

Johnson & Johnson will pay more than $2.5 billion to resolve more than 7,500 lawsuits involving defective ASR metal-on-metal hip implants made by its subsidiary DePuy Othopaedics. DePuy issued a worldwide recall on an estimated 93,000 of its ASR all-metal hip replacement systems in 2010 after reports that the devices were failing at a faster than expected rate. Traditional hip implants can last 20 years or more before needing to be replaced. However, a large number of DePuy’s ASR devices were failing in five years or less. Unlike traditional hip implants that are made with ceramic or plastic parts, the ... Read More

European Parliament considers stronger medical device oversight to better ensure patient safety

Europen Parliament is considering adopting a proposal that would give European drug and medical device regulators more control over medical devices, and require high-risk devices to undergo an approval process before they reach the market. In both Europe and the United States, most medical devices are cleared swiftly for marketing if they can prove they are similar to products already on the market. This has raised safety concerns in the past in both countries, especially after high-profile recalls and safety advisories including the worldwide recall of Johnson & Johnson’s DePuy Orthopaedic ASR metal-on-metal hip replacement system. The devices were granted ... Read More

3.4 million Japanese automobiles recalled due to faulty airbags

Four Japanese automobile makers are recalling 3.4 million vehicles sold worldwide because the airbags could catch on fire or injure passengers. The airbags were manufactured by Takata Corp., the world’s second largest supplier of airbags and seat belts. This is the largest airbag recall Takata has ever issued. The recall involves vehicles made by Toyota Motor Corp, Nissan Motor Co, Honda Motor Co Ltd, and Mazda Motor Corp. Toyota, Honda and Nissan said they are not aware of any injuries or deaths caused by the defective airbags. The problem is that during an accident the front passenger seat airbag may ... Read More

Failure of metal-on-metal hip implants causing pain for patients

Scott Ebert, 48, was so happy to experience relief from pain after receiving a new artificial hip made by Stryker that he named his new puppy after the medical device company. But two months later, Ebert was singing a different tune. Ebert’s artificial joint began slipping, causing his leg to give out unexpectedly. Sharp pains stabbed at his foot, and a sizeable bruise covered his calf. His hip burned with pain, his ears rang. Ebert rattled off an odd list of symptoms that only baffled his doctor, until he drew Ebert’s blood. Ebert’s artificial hip, known as the Rejuvenate, was ... Read More

Johnson and Johnson internal analysis shows recalled hip implant could have 40 percent failure risk

Not long after health care giant Johnson & Johnson and its subsidiary DePuy Orthopaedics issued a worldwide recall of the ASR hip replacement system and ASR hip resurfacing system due to a higher rate of premature failures than competitive devices, the company launched an internal analysis of its recalled metal-on-metal devices. What the company discovered is that the devices were far more defective than first thought. The analysis showed that the hip implants could be expected to fail within five years in an estimated 40 percent of patients who received the all-metal hip. It was data from the National Joint ... Read More

Johnson and Johnson to focus on medical devices, new drugs in 2013

Medical devices, new prescription drugs in development, and righting manufacturing problems will be the focus of health care giant Johnson & Johnson’s efforts in 2013, the company announced. Johnson & Johnson is rolling out this week its fourth-quarter results along with its 2013 forecast and providing a periodic update for analysts on its medical device and diagnostics division, which has grown to be the company’s largest segment bringing in about $26 billion in annual revenue. Johnson & Johnson makes everything from artificial joints and contact lenses to surgical devices and diabetes testing supplies. In 2010, its DePuy Orthopaedics subsidiary made ... Read More

FDA proposes requiring makers of metal hips to submit premarket approval applications

The Food and Drug Administration (FDA) is proposing requiring manufacturers of metal-on-metal total hip replacement systems to submit premarket approval applications in order to assess risks associated with the devices. The proposed order was announced Thursday along with updated safety information and recommendations for patients and health care providers about illnesses and injuries associated with the devices. Metal-on-metal hip replacement and resurfacing systems, unlike traditional hip systems made with ceramic or plastic parts, have a metal ball that moves within a metal socket. This movement can cause bits of metal debris to release into the joint space, causing soft tissue damage ... Read More

UK health regulator warns of problems with metal-on-metal hip implants

The risk from metal-on-metal hip replacement systems is greater than previously thought, with even greater failure rates, U.K. health regulator the Medicines and Healthcare Products Regulatory Agency (MHRA) reported. Artificial hips are traditionally made with ceramic or plastic parts, but over the past decade medical device manufacturers began making hip implants with all metal parts. The idea was that the new design would make the hips more durable over time. Traditional hip implants can last 20 years or more before they need replacing. However, shortly after the metal-on-metal hips hit markets around the world, reports of premature failures began pouring ... Read More

New consortium aims to improve safety of medical devices

The Food and Drug Administration (FDA) has caught much flack in the past couple years over its medical device approval process, with critics arguing that not enough effort is made to ensure the safety and efficacy of devices before they hit the market. In response, a new consortium of leaders from industry, academia and government agencies was formed to help guide the advancement of medical device regulatory science. The Medical Device Innovation Consortium (MDIC), is a public-private partnership with the FDA’s Center for Devices and Radiological Health (CDRH). FDA Commissioner Dr. Margaret Hamburg called the formation of the consortium a ... Read More