(Dec. 20, 2012) The Food and Drug Administration announced today that Zimmer Spine, Inc. is initiating an urgent voluntary worldwide recall of all 315 units of the company’s PEEK Ardis Inserter.
The Ardis Inserter is a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer. Officials said 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.
Officials said 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.
Company officials said that so far no post-operative complaints have been reported that are attributed to a fractured implant and that patients with concern about their implant should contact their health care provider.
The FDA said surgeons and hospitals with PEEK Ardis Inserter instruments should immediately stop using the inserters and return them to Zimmer Spine.
Officials said that 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 that were distributed from June 2008 through December 2012.
Officials said the lot numbers are listed on the Zimmer web site and affected products can be identified by the part number and lot number physically marked on the surgical instrument.
The affected products were distributed nationwide in the United States and around the world. Zimmer Spine has notified the FDA of this action and is working with other regulatory agencies worldwide.
Zimmer officials said they are notifying distributors and customers worldwide via a letter and is arranging for the return of all PEEK Ardis Inserters. Further information, including a detailed listing of part and lot numbers, is available at the company web site.
Health care professionals or customers may report adverse events or quality problems experienced with the use of these products to Zimmer Spine by calling 866-774-6368 between the hours of 8AM and 5PM CST or by email at firstname.lastname@example.org.
Adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.