Synthes—1st Generation Sternal ZipFix Systems: Implant May Be Cut While Tensioning Trigger is Being Squeezed
August 28, 2013 | Risk Management News
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In an August 15, 2013, Urgent Medical Device Notification letter submitted by an ECRI Institute member hospital, Synthes states that during use of the systems below, the implant may be cut while the tensioning trigger is being squeezed, potentially loosening the implants after implantation or during the postoperative recovery period. A loose implant may...