Zimmer Spine Recall Gets FDA’s Top Warning
Zimmer Spine’s global recall of its spinal surgical devices has been labeled a Class I recall by the U.S. Food and Drug Administration (FDA) – the agency’s most serious warning.
The FDA issues a Class I when there is the potential for a product to cause serious health problems or death.
The initial recall of 315 units of the PEEK Ardis Inserter was initiated by Zimmer Spine last month after the company received reports that there was a 0.52 percent rate of risk of a fracture occurring during surgery. The inserter is used during spinal surgery to implant the PEEK Ardis Interbody Spacer. The inserters were putting excessive pressure on the spacers. which could lead them to break.
The FDA says that if the PEEK Ardis Interbody Spacer breaks on implantation, it may cause surgical delays of more than 60 minutes and the consequence may be a tear in the thin covering of the spinal cord, cerebrospinal fluid leakage, blood loss, nerve injury. The long term consequences could be disability, dysfunction, and even death.
The lots affected by the recall are the ones distributed during June 2008 and December 2012.
If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you.