FDA-Device2019-12-18Class II
Healix Knotless ADV BR 5.5 Suture Anchor
DePuy Mitek, Inc., a Johnson & Johnson Co.
Hazard
Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors were manufactured with BIOCRYL" Biocomposite Material instead of BIOCRYL RAPIDE¿ Biocomposite Material. BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective material choices for absorbable, injection-molded sports medicine implant fixation.
Sold states
US: AL AZ CA CT FL IA IL IN LA MA MD ME MI MN MT NC NE NH NJ NM OH OK OR PA TN TX VA WA WI International: Belgium, Chile, China, Czech Republic, France, India, Japan, Korea, Latvia, New Zealand, Slovakia Sweden
Affected count
599
Manufactured in
249 Vanderbilt Ave, N/A, Norwood, MA, United States
Products
Healix Knotless ADV BR 5.5 Suture Anchor
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0666-2020Don't want to check this manually?
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