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Who this can affect: Patients undergoing brain shunt surgery using the Integra NeuroSciences Gravity Compensating Accessory
In 2008, Integra NeuroSciences recalled the Gravity Compensating Accessory because of a manufacturing defect. The defective device may have caused inflammation of the spinal cord, brain or abdominal membranes in patients who underwent brain shunt surgery. It may also cause pressure on the wound or failure of the shunt system. The FDA labeled this recall as Class I, the most serious type of recall indicating that the device poses a probable risk for serious injury or death.
The accessory contains stainless steel balls that change flow resistance through a ball and cone mechanism. According to the FDA, the product was recalled because it may leak cerebrospinal fluid.
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This message was edited by MOD1 on 2-5-09 @ 12:17 PM
MOD1
02-05-2009 @ 12:16 PM