Synthes—Tensioning Devices Used with Distraction Osteogenesis Ring Systems: Reaction Fork May Loosen, Preventing Wire Release and Tension Application
August 21, 2013 | Strategic Insights for Health System
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In a July 31, 2013, Urgent Notice Medical Device Recall letter submitted by ECRI Institute member hospitals, Synthes states that the reaction fork may loosen from the main body of the tensioning devices below, preventing the wire from being released and the device from applying tension, and potentially resulting in a surgical delay. Synthes also states that it has received no reports of adverse events related to this problem. The manufacturer has not confirmed the...