201301.04
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Zimmer Spine Complications – Defective Inserter

Zimmer Spine Complications Could be Caused by Defective Inserter

Zimmer and the FDA are alerting surgeons and risk managers that the PEEK Ardis Inserter is not safe for use and is being recalled – patients who had Zimmer components inserted during back surgery and suffered complications or death should check to see if the defective PEEK Ardis Inserter was used during surgery.   The use of the PEEK Ardis Inserter during spine surgery could cause disability, dysfunction, or death, according to the FDA.   The Merman Law Firm is helping to spread the word to potential victims of Zimmer Spine Complications – Defective Inserter.  Spine surgery patients that experienced complications or death following implantation of a Zimmer Spine listed below should contact the Merman Law Firm immediately to see if the PEEK Ardis Inserter was the cause of the complications.

The PEEK Ardis Inserter, manufactured by Zimmer Spine, Inc., is a surgical tool used to implant the PEEK Ardis Interbody Spacer during spine surgery.  The company received reports that the PEEK Ardis Interbody Spacer was breaking into fragments when too much force was applied to the Inserter. In November 2012, the company issued a memo to warn surgeons and medical facilities of the defect and provide them with precautionary measures. Since then, the company has issued a voluntary recall of all Inserters and informed medical personnel to immediately stop using the surgical device.

Zimmer Spine Complications – Defective Inserter

If the PEEK Ardis Interbody Spacer fractures during surgery, the following complications may ensue:

  • Surgical delays of up to one hour
  • Tear(s) in the covering of the spinal cord, a “dural tear”
  • Cerebrospinal fluid leakage
  • Significant blood loss
  • Nerve injury

Though medical facilities and medical professionals have been instructed to cease use of this product, patients may still be at risk.