Z-0666-2020 Class II Terminated
FDA device recall Z-0666-2020 was initiated by DePuy Mitek, Inc., a Johnson & Johnson Co. on November 4, 2019 and is designated Class II. 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 BIOCRY… The recall status is terminated (terminated May 5, 2020). Affected quantity: 599.
Recall Details
- Product Type
- Devices
- Report Date
- December 18, 2019
- Initiation Date
- November 4, 2019
- Termination Date
- May 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 599
Product Description
Healix Knotless ADV BR 5.5 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.
Distribution Pattern
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
Code Information
Part Number: 222331 Batch/Lot: 5L45259, 5L13543 GTIN: 10886705023479