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News Breaks
December 28, 2012
11:38 EDTZMHZimmer recalls all 315 units of PEEK Ardis Inserter, FDA says
The FDA posted on its website that Zimmer issued a December 21 recall of its PEEK Ardis Inserter. Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter, the FDA said. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur and health risks may include a tear in the thin covering of the spinal cord, cerebrospinal fluid leakage, significant blood loss and nerve injury, the agency added. On Dec. 20, Zimmer Spine modified their Medical Device Correction memo and initiated a voluntary recall of all 315 units of the PEEK Ardis Inserter.
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