The device manufacturer received reports of its spacer breaking into fragments because of the Ardis inserter. Such breaks delay surgery and could result in spinal cord tears, cerebrospinal fluid leakage, blood loss or nerve injury.
The PEEK Ardis Implant System will not be available for use or purchase until it is redesigned and cleared by federal regulators.
Class 1 recalls are the most serious type and involve situations that could result in death, according to the FDA.
More Articles on Devices:
Smith & Nephew CFO to Resign
Recall Issued for Medtronic Infusion Pumps
Omeros Shares Drop 9% After Knee Surgery Clinical Trial Results Released
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.