The tool is being recalled because Zimmer has received reports of the spine spacer breaking under pressure from the inserter.
All 315 units have been recalled. Health risks from the implant fragments include dural tears and blood loss. Parts were distributed from June 2008 to December 2012.
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Zimmer Issues Urgent Recall of Interbody Spacer Inserter FeaturedWritten by Heather Linder | Thursday, 20 December 2012 20:13
Zimmer issued an urgent recall of its PEEK Ardis Inserter, an instrument for implanting the PEEK Ardis Interbody Spacer in the spine.
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