On December 21, 2012, Zimmer Spine, Inc. issued a voluntary recall of all 315 units of the company's PEEK Ardis Inserter, a surgical instrument used to insert the PEEK Ardis Interbody Spacer. There have been reports that the Interbody Spacer breaks into fragments during surgery when too much lateral force is applied to the defective Inserter. When such a break occurs, the surgery may be delayed by an hour and may lead to serious complications that put the patient in danger. These dangers include a tear in the spinal covering, loss of blood, and nerve damage. Long-term risks of this complication include disability, dysfunction, and even death.
Zimmer initially issued a memo in November to physicians warning them of the suspected problem and suggesting precautions to prevent breakage. The company decided to issue a full recall last week. The surgery to implant the Interbody Spacer can only be done using the Inserter, so the system will be unavailable to patients until the FDA approves a new design for the Inserter. Zimmer states it will have a redesigned Inserter available sometime in May 2013.
If you have questions for Zimmer Spine, you may call the company at 1-866-774-6368, Monday through Friday from 8 am to 5 pm Central Time.