Recall Z-0666-2020 ยท MAI Fastener, Fixation, Biodegradable, Soft Tissue
DePuy Mitek, Inc., a Johnson & Johnson Co.
Healix Knotless ADV BR 5.5 Suture Anchor
| Date | Nov 4, 2019 |
| Status | Terminated |
| 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. |
| Root cause | Employee error |
| Action | On November 4, 2019 the firm distributed Urgent Medical Device Recall Communication letters by mail: URGENT FIELD SAFETY NOTICE PRODUCT RECALL HEALIX ADVANCE" Knotless Anchors Dear Valued Customer, On 04-November-2019, DePuy Mitek, Inc. initiated a Voluntary Product Removal of specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors. The 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 |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K130917 | HEALIX ADVANCE KNOTLESS BR ANCHOR Depuy Mitek, A Johnson & Johnson Company, May 24, 2013 |