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Recall issued for Gibralt polyaxial screw

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The FDA has issued a class 2 device recall for the Gibralt Spine System Polyaxial Screw, part of the Gibralt Spinal System available from Exactech. The screw is intended to promote fusion of the cervical and thoracic spine.

According to the FDA notice, the recall came as a result of a material combination which may lead to corrosion over time. While the product was intended to contain springs manufactured with a titanium alloy to prevent corrosion, it was found to have type-304 stainless steel used in the manufacturing of the springs.

Exactech sent an urgent product recall notice on Jan. 6 to all affected customers, which identified the product and described the specific action needed to be taken. The product’s current distribution in the United States includes Florida, New York, Oregon, Illinois, Pennsylvania, Missouri and New Jersey.