Healix Knotless ADV BR 5.5 Suture Anchor recall
Healix Knotless ADV BR 5.5 Suture Anchor
Why was Healix Knotless ADV BR 5.5 Suture Anchor 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Part Number: 222331 Batch/Lot: 5L45259, 5L13543 GTIN: 10886705023479
- Product
- Healix Knotless ADV BR 5.5 Suture Anchor
- Recalling firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Quantity
- 599
- 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
- Recall date
- December 18, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)