All PEEK Ardis Inserters are the subject of a worldwide recall. The Ardis Inserter is a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer. The inserters are being recalled because the manufacturer, Zimmer Spine, has received reports of PEEK Ardis Interbody Spacer implant breakage when the implant is subjected to excessive lateral and/or off-axis forces from the inserter during surgery. Intra-operative complaint reports received to date indicate an occurrence rate of 0.52%. Observed health risks associated with implant fragments may include dural tears and blood loss.
Surgeons and hospitals with PEEK Ardis Inserter instruments should immediately stop using the inserters and return them to Zimmer Spine. Surgery using the PEEK Ardis Interbody Spacer cannot be performed as intended without the aid of the PEEK Ardis Inserter instrument.
This recall includes lots distributed from June 2008 through December 2012 in the United States and around the world. Products can be identified by the part number and lot number physically marked on the surgical instrument.
See the Recall