DePuy Synthes—Trochanteric Fixation Nail Advanced Blade/Screw Guide Sleeves: Outer Diameter May Exceed Specifications
June 22, 2016 | Strategic Insights for Health System
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ECRI Institute's complete weekly summary of medical device hazard and recall information is available in ECRI Institute's Health Devices Alerts(HDA). For more information about HDA, contact us at clientservices@ecri.org.
In a June 8, 2016, Urgent Notice Medical Device Recall letter submitted by an ECRI Institute member hospital, DePuy Synthes states that the above guide sleeves may have been manufactured with a slightly larger-than-specified outer diameter that could prevent the sleeve from properly going through the TFNA aiming arm, potentially delaying surgery. The manufacturer has not confirmed the...