Medical device developer Zimmer Holdings has been given Class I status from the FDA for a global recall of its PEEK Ardis Inserter instruments over concerns that the devices could lead to problems during surgery, including severe bleeding. The December recall came on the heels of reports that the inserters may put too much pressure on the Ardis Interbody Spacers. The recall covers specific lots distributed from June 2008 to December 2012.
FDA labels Zimmer recall as Class I
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