Device product
Healix Knotless ADV BR 5.5 Suture Anchor
Z-0666-2020
Product summary
- Event
- Event 84237
- Status
- Terminated
- Classification
- Class II
- Quantity
- 599
- Official record key
device-enforcement:Z-0666-2020
Official wording
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 information: Part Number: 222331 Batch/Lot: 5L45259, 5L13543 GTIN: 10886705023479
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
Derived failure modes
-
Unknown
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.