Recall Class: Class I
Date Recall Initiated: December 21, 2012
Product: PEEK Ardis Inserter
Manufacturing and Distribution Dates: June 2008 – December 201
The affected models and lot numbers: Affected lots and part numbers are available on the FDA's website.
Use: The PEEK Ardis Inserter is a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer.
Zimmer Spine, Inc
7375 Bush Lake Road
Minneapolis, Minnesota 55439
Reason for Recall: Zimmer Spine has received reports of the PEEK Ardis Interbody Spacer breaking into fragments when too much lateral force is applied to the Ardis Inserter. If the PEEK Ardis Interbody Spacer breaks during implantation, surgical delays of up to 60 minutes could occur and health risks may include a tear in the thin covering of the spinal cord (dural tear), cerebrospinal fluid leakage, significant blood loss and nerve injury. Long-term health risks may include disability, dysfunction, or death.
Public Contact: Questions should be directed to Zimmer Spine at 1-866-774-6368, Monday through Friday from 8 am to 5 pm Central Time.
FDA District: Detroit
FDA Comments: Initially, in November 2012, Zimmer Spine issued a Medical Device Correction memo to inform surgeons and hospitals of the problem and to provide updated precautions and surgical technique guidance to decrease the risk of implant breakage. In this memo, Zimmer Spine also indicated that on or about May 2013, a redesigned inserter would be available for use when implanting the PEEK Ardis Interbody Spacer.
On Dec. 20, 2012, Zimmer Spine modified their Medical Device Correction memo and initiated a voluntary recall of all 315 units of the PEEK Ardis Inserter. Surgeons and hospitals were instructed to immediately stop using the Ardis Inserter and to return them to Zimmer Spine. Surgeons and hospitals should be aware that surgery using the PEEK Ardis Interbody Spacer cannot be performed as intended without the use of the Ardis Inserter. Therefore the PEEK Ardis Implant System will be unavailable for use until a redesigned inserter is cleared by the FDA.
Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.
Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.