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.
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
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.