Medical Device Recall Announced By Zimmer Spine

Medical device maker Zimmer Spine Inc. issued an urgent worldwide recall of 315 units of its PEEK Ardis Inserter, a surgical instrument used during spinal surgery to implant the PEEK Ardis Interbody Spacer.

Zimmer Spine issued the voluntary recall for the inserter instrument after receiving reports that the spacer implant may break when subjected to “excessive lateral and/or off-axis forces from the inserter during surgery.”

Zimmer Spine says that based on the reports there is a 0.52% risk of breakage. The health risks due to the breakage may include dural tears and blood loss.

However, there have been no post-operative complaints attributed to a fractured implant so far.

Zimmer Spine has advised patients with safety concerns about their implant to contact their healthcare provider. Surgeons and hospitals with PEEK Ardis Inserter instruments should immediately stop using the inserters and return them.

The recall includes all lots of part 3256-01 that were distributed from June 2008 through December 2012.

Zimmer Spine is working in the recall in collaboration with the U.S. Food and Drug Administration and other regulatory agencies worldwide; and customers and distributors will be informed of the recall via letters.

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.

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