FDA Warning Prompts DePuy Orthopaedics to Halt Sale of Custom Joint Replacements
Nadrich & Cohen, LLP reports that Johnson & Johnson's DePuy Orthopaedics is halting the sale of certain custom joint replacements after receiving a warning from the U.S. Food and Drug Administration.
Johnson & Johnson's DePuy Orthopaedics says it will stop selling custom-fitted joint replacement devices after being warned by the U.S. Food and Drug Administration that the products were not in compliance with the organization's approval guidelines.
In a letter dated December 8, the FDA said that DePuy manufactured 14 types of devices, including hip and knee replacement systems, without obtaining pre-market clearance or proper approval. DePuy argued that the devices in question were custom-made for specific patients and did not require additional approval but the FDA disagreed.
According to the Asbury Park Press, the FDA issued a letter this week warning DePuy that pre-market approval or new 510(k) applications would be required for all custom devices and components the company sold. DePuy has since suspended the sale of all custom devices and says it will also address concerns raised by the FDA over quality issues.
The FDA's latest warning only adds to the troubles faced by DePuy. The company is currently being sued by a number of patients who claim they were seriously injured by one of the company's metal hip implants. Mounting consumer complaints lead the company to recall its ASR hip replacement system in 2010. Many patients who received one of the metal hips reported severe pain, swelling, tissue damage, metallosis and other serious side effects.
If you or a loved one has experienced complications after receiving a metal hip implant, you may complete a MedWatch form by visiting http://www.fda.gov. It's also recommended that you contact an experienced hip implant injury attorney to discuss your legal rights.
Nadrich & Cohen LLP offers confidential, no-cost consultations to patients across the country who believe they were harmed by a defective hip. Help is available by calling the firm's injury hotline at 1-800-722-0765 or by completing an online case evaluation form at http://www.depuyhipreplacementlawyers.net.
Nadrich & Cohen LLP is a national law firm with offices in Los Angeles, Sacramento, San Diego and other cities throughout California specializing in handling mass tort actions and representing individuals in cases involving pharmaceutical companies and medical device manufacturers. The firm is committed to achieving the best outcome possible in every case and has recovered over $200 million in settlements on behalf of its clients.
In addition to handling DePuy and Zimmer hip claims, Nadrich & Cohen LLP is also investigating cases involving Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Vaginal Mesh, Wright Conserve Hips, Yaz, Yasmin, Stevens-Johnson Syndrome, Benzene, Reflex Sympathy Dystrophy, Fen Phen and PPH, Depakote and Reglan.
The time you have to file an injury claim is limited, so it's important to act as quickly as possible to protect your rights. Call 1-800-722-0765 today to speak with a qualified personal injury expert or visit http://www.personalinjurylawcal.com.
Johnson & Johnson's DePuy Orthopaedics says it will stop selling custom-fitted joint replacement devices after being warned by the U.S. Food and Drug Administration that the products were not in compliance with the organization's approval guidelines.
In a letter dated December 8, the FDA said that DePuy manufactured 14 types of devices, including hip and knee replacement systems, without obtaining pre-market clearance or proper approval. DePuy argued that the devices in question were custom-made for specific patients and did not require additional approval but the FDA disagreed.
According to the Asbury Park Press, the FDA issued a letter this week warning DePuy that pre-market approval or new 510(k) applications would be required for all custom devices and components the company sold. DePuy has since suspended the sale of all custom devices and says it will also address concerns raised by the FDA over quality issues.
The FDA's latest warning only adds to the troubles faced by DePuy. The company is currently being sued by a number of patients who claim they were seriously injured by one of the company's metal hip implants. Mounting consumer complaints lead the company to recall its ASR hip replacement system in 2010. Many patients who received one of the metal hips reported severe pain, swelling, tissue damage, metallosis and other serious side effects.
If you or a loved one has experienced complications after receiving a metal hip implant, you may complete a MedWatch form by visiting http://www.fda.gov. It's also recommended that you contact an experienced hip implant injury attorney to discuss your legal rights.
Nadrich & Cohen LLP offers confidential, no-cost consultations to patients across the country who believe they were harmed by a defective hip. Help is available by calling the firm's injury hotline at 1-800-722-0765 or by completing an online case evaluation form at http://www.depuyhipreplacementlawyers.net.
Nadrich & Cohen LLP is a national law firm with offices in Los Angeles, Sacramento, San Diego and other cities throughout California specializing in handling mass tort actions and representing individuals in cases involving pharmaceutical companies and medical device manufacturers. The firm is committed to achieving the best outcome possible in every case and has recovered over $200 million in settlements on behalf of its clients.
In addition to handling DePuy and Zimmer hip claims, Nadrich & Cohen LLP is also investigating cases involving Accutane, Actos, Avandia, Fosamax, Paxil, Zoloft, Vaginal Mesh, Wright Conserve Hips, Yaz, Yasmin, Stevens-Johnson Syndrome, Benzene, Reflex Sympathy Dystrophy, Fen Phen and PPH, Depakote and Reglan.
The time you have to file an injury claim is limited, so it's important to act as quickly as possible to protect your rights. Call 1-800-722-0765 today to speak with a qualified personal injury expert or visit http://www.personalinjurylawcal.com.
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