Integra—Endoscopic Gastrocnemius Release Systems: Blade May Not Retract Following Recession of Gastrocnemius Aponeurosis
January 18, 2012 | Risk Management News
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In a January 6, 2012, Urgent Medical Device Correction Notice letter submitted by an ECRI Institute member hospital, Integra states that it has received reports that the blade of the systems below may not retract into the device following recession of the gastrocnemius aponeurosis. Integra also states that it has received no reports of adverse events or patient injury related to this problem. The manufacturer has not confirmed the...