FDAFDA · Food and drugs·Recall number Z-0665-2020
Healix Knotless ADV BR 4.75 Suture Anchor
Published December 18, 2019 · Recall initiated: November 4, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Distributor
- 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
- Lot
- Part Number: 222330 Batch/Lot: 5L45257 GTIN: 10886705023462
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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