Healix Knotless ADV BR 4.75 Suture Anchor
Reported: December 18, 2019 Initiated: November 4, 2019 #Z-0665-2020
Product Description
Healix Knotless ADV BR 4.75 Suture Anchor
Reason for Recall
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.
Details
- Recalling Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Units Affected
- 299
- Distribution
- 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
- Location
- Norwood, MA
Frequently Asked Questions
What product was recalled? ▼
Healix Knotless ADV BR 4.75 Suture Anchor. Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co.. Units affected: 299.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2019. Severity: Moderate. Recall number: Z-0665-2020.
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