FDA Issues Class I Recall for ICON Modular Spinal Fixation System and FDA Issues Recall of Boca Medical Ultilet Insulin Syringe

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Subject:

FDA Issues Class I Recall for ICON Modular Spinal Fixation System and FDA Issues Recall of Boca Medical Ultilet Insulin Syringe

Category:

Food and Drug Administration (FDA)

Published:

Wed, 19 Apr 2006 - 10:00 am

CLASS 1 MEDICAL DEVICE RECALLS - Blackstone Medical, Inc. ICON Modular Spinal Fixation System (Model #54-1090; 54-1091; 54-1092, distributed between June and December 2005) The ICON Modular Spinal Fixation System contains a variety of screws, rods and connectors implanted in and near the patient's spine to immobilize and stabilize spinal segments at the site of spine surgery. The device is being recalled because the pedicle (vertebra stem) screws may separate from the screw heads, or from the...

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