RTI Surgical—Streamline MIS Navigation System Taps: May Not Be Compatible with Streamline MIS Tap Sleeves
November 18, 2020 | Risk Management News
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FDA's Center for Devices and Radiological Health (CDRH) states that the above taps may not be compatible with the Streamline MIS tap sleeve. Streamline MIS Navigation taps becoming bound within Medtronic's Stealth Navigation System NavLock Tracker was reported. FDA's CDRH also states that the manufacturer initiated a recall by letter on September 24, 2020. The manufacturer has not confirmed the...