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After issuing at least two written warnings to Shelhigh, Inc. regarding its substandard manufacturing processes, the Food and Drug Administration together with U.S. Marshals seized all of the company's implantable medical devices in April 2007. The seizure follows—in addition to the two Shelhigh warning letters issued in 2000 and 2005—an FDA inspection of the company's manufacturing facility in the fall of 2006 exposing significant safety violations. Shelhigh's manufacturing violations may have compromised the safety and sterility of the medical devices, putting thousands of Americans at risk of serious infection or injury.

Individuals who suffer adverse health effects as a result of a Shelhigh defective medical device may be able to recover compensation for their injuries and suffering by filing a claim against the company. To speak with a Shelhigh implant lawyer, please contact us today.

Shelhigh Warning & Device Seizure

Medical device makers are required to adhere to strict manufacturing practices to ensure the safety, sterility and efficacy of their products. Even though the FDA issued a number of Shelhigh warnings, the company failed to comply with standard safety practices and, as a result, all of its medical devices were seized, including:

• Pediatric heart valves and conduits
• Surgical patches
• Dural patches
• Arterial grafts
• Annuloplasty rings

The FDA safety alert urged physicians to monitor patients implanted with Shelhigh devices for possible infection or other serious injury that may result from a defective product. According to agency officials, those who face the greatest risk are pediatric patients, gravely ill patients, and patients with compromised immune systems.

Know Your Legal Rights

If you have been implanted with a Shelhigh defective medical device, you need to know your legal rights and options. You may be entitled to financial reimbursement for your medical costs, pain and anguish, and more. A qualified Shelhigh implant lawyer can evaluate your case, help you understand your options, and ensure your legal rights are fully protected.

Please contact us today to schedule a complimentary consultation with an experienced attorney near you.

"Shelhigh's Product Distribution Stopped"

An injunction entered yesterday in the U.S. District Court forbids the Union, N.J. company Shelhigh from distributing the medical devices it manufactures until the company's fac...

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