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FDA and Zimmer Spine, Inc. Issue Recall for Surgical Implant Inserter

Jan. 2, 2013

The U.S. Food and Drug Administration (FDA) announced recently that Zimmer Spine, Inc. had issued a voluntary recall on its PEEK Ardis® Inserter. According to an FDA press release, defects in the device can seriously injure patients during corrective spinal surgeries.

The PEEK Ardis® Inserter is used to place the PEEK Ardis Interbody Spacer implant in between spinal discs during reconstructive or corrective spinal surgeries. However, the FDA and Zimmer began receiving reports of the implants breaking during insertion when excessive force was used. Breakage can result in patients suffering from blood loss, nerve damage, spinal fluid leakage, and tears of the outer-most layer of tissue covering the spine, known as the dura. The FDA added that long-term risks of these injuries include disability, dysfunction, and possibly death.

The recall was issued on Dec. 20, with a total of 315 units affected by the recall. A complete list of affected instrument sets is published within the FDA press release.

Physicians and hospitals in possession of affected products should halt the use of the Defective Products and contact the manufacturer immediately.

The Pueblo Personal Injury Lawyers with McDivitt Law Firm recognize the dangers the use of a defective product during surgery can present and recommend discussing your legal options with a qualified attorney if you have been harmed while under a doctor’s care.

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