Smith & Nephew—SUTUREFIX ULTRA Suture Anchor: Packaging May Contain the Wrong Size Drill
August 12, 2020 | Risk Management News
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FDA's Center for Devices and Radiological Health (CDRH) states that packages of the above sutures labeled as containing a 1.7 mm twist drill (S) instead contain a 1.7 mm (XL) drill. The overall length of the XL drill (12 inches) is longer than the S drill (11 inches). FDA's CDRH also states that the manufacturer initiated a recall by Urgent Medical Device Recall Notice letter on June 24, 2020. The manufacturer has not confirmed the...