Smith & Nephew—SUTUREFIX ULTRA Suture Anchor: Packaging May Contain the Wrong Size Drill

August 12, 2020 | Risk Management News

Preview

​ECRI's complete weekly summary of medical device hazard and recall information is available in ECRI's Health Device Alerts. For more information contact us at clientservices@ecri.org.

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...

Access Full Content

Contact us today at 610.825.6000.

Related Tags