Healix Knotless ADV BR 5 recalled over mold contamination

Recall date

November 4, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

DePuy Mitek, Inc., a Johnson & Johnson Co. recalls Healix Knotless ADV BR 5.5 Suture Anchor

Recall number

Z-0666-2020

FDA classification

Class II

Brand / firm

DePuy Mitek, Inc., a Johnson & Johnson Co.

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Healix Knotless ADV BR 5.5 Suture Anchor