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Zimmer Spinal Surgical Instruments Recalled, Given FDA’s Most Serious Recall Score

Filed January 2nd, 2013 Laurie

Over 300 spinal surgical instruments known as Peek Ardis Inserters were recalled last week by Zimmer Holdings, which said the devices could cause serious injury or death.

The U.S. Food and Drug Administration (FDA) just made the announcement after Zimmer recalled 315 of the inserters on December 20. Zimmer said it decided to pull the devices because they could cause “surgical delays and injury” when used in spinal surgery. According to the firm, too much pressure placed on the inserter could cause another implant to break during surgery, which could damage the cover of the spinal cord, or cause blood loss or nerve injury, PharmPro reported.

The FDA has classified the recall as a Class I, its most serious recall designation. Patients treated with the recalled products could be seriously injured or killed. The agency said the Peek Ardis Inserters are an essential part of Zimmer’s Peek Ardis Implant System, the Inserters will not be available until a redesigned inserter is cleared by the FDA, said PharmPro.

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