Zimmer Spine - PEEK Ardis Inserter: Class I Recall – Risk of Implant Breakage
AUDIENCE: Surgery, Risk Manager
ISSUE: 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.
BACKGROUND: The PEEK Ardis Inserter is a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer.
RECOMMENDATION: On Dec. 20, 2012, Zimmer Spine modified their November 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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178