Zimmer Recalls Spinal Tool

Zimmer Spine is conducting a Class I recall of its PEEK Ardis Inserter, saying it may cause the PEEK Ardis Interbody Spacer to break when inserted into the spine if too much force is used. The company is asking all 315 hospitals using the Ardis Inserter to cease doing spinal surgery with the interbody spacer and return the products. A redesigned inserter is planned for May 2013. The affected units were distributed between June 2008 and December 2012.
The GMP Letter