Zimmer issued an urgent recall of its PEEK Ardis Inserter, an instrument for implanting the PEEK Ardis Interbody Spacer in the spine. 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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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.
More Articles on Devices:
Aurora Spine Announces British Standards Institute Certification
Ascendx Spine VCF Repair System Receives FDA Clearance
iFuse Spine Implant System Study Published in Peer-Reviewed Journal