Zimmer Spine launches urgent global recall

December 20, 2012 by MassDevice staff

Orthopedic devices maker Zimmer's spine business orders an urgent global recall of certain PEEK spinal surgery instruments over reports of breakage during surgery.

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Medical device giant Zimmer Holdings (NYSE:ZMH) launched an urgent worldwide recall of its PEEK Ardis Inserter instruments after receiving reports that they may fracture Ardis Interbody Spacers during spinal surgery.

There are about 315 units to recall, according to a press release, and no adverse events associated with the fractured devices have yet been reported.

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The Ardis Inserter is the only device that can be used to implant Zimmer's Ardis Interbody Spacer, a device used to "facilitate efficient, versatile and reproducible spinal fusion procedures," according to the company's website.

Zimmer received reports that the inserters may exert excessive force on the spacers, causing them to fracture during surgery. Breakage reports received thus far suggest an occurrence rate of 0.52%, Zimmer noted.

Potential adverse events associated with fractured spacers include dural tears and blood loss, according to the report.