EnDura No-React Dural Substitute

Modified on 2009/10/14 21:51 by admin
FDA Recalls Products for Use in Neurosurgery

Updated June 5- The FDA has issued a Class 1 recall on all Integra LifeSciences Corporation (also known as Integra NeuroSciences) EnDura™ No-React Dural Substitute® products. A class 1 recall is the most serious classification of FDA product recall because the product is most likely to cause serious injury or death. EnDura™ No-React Dural Substitute® is used to repair the dura matter during neurosurgery; the dura matter is the tough, fibrous membrane covering the brain and the spinal cord and lining the inner surface of the skull.

FDA officials issued an immediate recall and ordered Federal marshalls to seize contaminated products at Integra Life Sciences Corporation’s Shelhigh, NJ plant, after it was discovered in routine FDA evaluations that the environmental controls and sterility processes used to manufacture these devices had been seriously compromised. The use of non-sterile products in patients during surgery can lead to life-threatening conditions. This is especially true of neurosurgery. The FDA recall concerns any patients who have had brain surgery (neurosurgery) since October 2003.

Injuryboard attorneys are evaluating claims pursuant to the recall now. If you or a family member have had neurosurgery since 2003 and been injured as a result of these defective products, it is important to find out what your legal rights are. An Injuryboard attorney will review your case FREE just by filling out the form to the right.

See Also

  1. Medical Devices & Implants
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