Zimmer Spine Issues Urgent Worldwide Medical Device Recall of the Inserter Instrument for the PEEK Ardis® Interbody Spacer (press release)
MINNEAPOLIS, MN) December 20, 2012—Zimmer Spine, Inc. is initiating a voluntary worldwide recall of all 315 units of the PEEK Ardis® Inserter. The Ardis Inserter is a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer. The inserters are being recalled because 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. No post-operative complaints have been reported that are attributed to a fractured implant. Patients with concern about their implant should contact their healthcare provider.
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 inten...
