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U.S. Department of Health and Human Services

Safety

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Shelhigh, Inc. Implantable Medical Devices

Audience: Cardiovascular, neurosurgical and other surgical healthcare professionals, hospital risk managers, consumers

[UPDATE 06/25/2007] FDA informed healthcare professionals of the United States District Court for the District of New Jersey's consent order of injunction, agreed to by Shelhigh, that forbids Shelhigh from distributing its implantable medical devices, used in heart surgery and other procedures, until the company brings its production processes in line with FDA standards.

[UPDATE 05/18/2007] FDA informed healthcare professionals that all medical devices manufactured by the company were manufactured under conditions that may have contaminated the devices and may result in devices that fail to function for the expected life of the products.

[UPDATE 05/02/2007] Recall expanded to include all Shelhigh medical devices remaining in the marketplace, including hospital inventories, because of sterility concerns.

[UPDATE 04/21/2007] Preliminary Public Health Notification and Preliminary Advice for Patients updated, based on information obtained during seizure.

[Posted 04/18/2007] FDA seized all implantable medical devices from Shelhigh, Inc., after finding significant deficiencies in the company’s manufacturing processes. The tissue-based devices are used in many surgical settings, including open heart surgery in adults, children and infants, and to repair soft tissue during neurosurgery and abdominal, pelvic and thoracic surgery. The deficiencies may compromise the safety and effectiveness of the products, particularly their sterility. Critically ill patients, pediatric patients and immuno-compromised patients may be at greatest risk from the use of these devices.

Physicians should use alternative devices. Physicians should also monitor patients with any Shelhigh implants for infections and proper device functioning over the expected lifetime of the device. Patients who think they may have received a Shelhigh device during surgery should contact their physician for more information.

[June 25, 2007 - News Release - FDA]
[May 18, 2007 - Updated Preliminary Public Health Notification - FDA]
[May 02, 2007 - News Release - FDA]
[April 19, 2007 - Updated Preliminary Advice for Patients - FDA]
[April 18, 2007 - Preliminary Public Health Notification - FDA]
[April 18, 2007 - Preliminary Advice for Patients - FDA]
[April 17, 2007 - Press Release - FDA]