FDA Enforcement
Class II
Terminated
Healix Knotless ADV BR 5.5 Suture Anchor
Recall: Z-0666-2020
·
Reported December 18, 2019
Enforcement
- Recall Number
- Z-0666-2020
- Event ID
- 84237
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2019
- Initiation Date
- November 4, 2019
- Classification Date
- December 10, 2019
- Termination Date
- May 5, 2020
- Address
- 249 Vanderbilt Ave, N/A, Norwood, MA, 02062-5033, United States
Description
Healix Knotless ADV BR 5.5 Suture Anchor
Reason
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.
Code Info
Part Number: 222331 Batch/Lot: 5L45259, 5L13543 GTIN: 10886705023479
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
Quantity
599