Z-0665-2020 Class II Terminated
FDA device recall Z-0665-2020 was initiated by DePuy Mitek, Inc., A Johnson & Johnson Co. on Nov 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… The recall status is terminated (terminated May 5, 2020). Affected quantity: 299.
Recall details
- Product Type
- Devices
- Report Date
- Dec 18, 2019
- Initiation Date
- Nov 4, 2019
- Termination Date
- May 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 299
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.
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: 222330 Batch/Lot: 5L45257 GTIN: 10886705023462
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0665-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026