Recall Z-0666-2020— DePuy Mitek, Inc., a Johnson & Johnson Co.

Name: FDA recall Z-0666-2020
Creator: U.S. Food and Drug Administration
Published: 2019-11-04

Class II · Terminated

Class II FDA medical device recall by DePuy Mitek, Inc., a Johnson & Johnson Co., initiated 2019-11-04, terminated 2020-05-05. It names one FDA 510(k) clearance: K130917. Product: 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..

Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson Co.
Classification: Class II
Status: Terminated
Initiated: 2019-11-04
Terminated: 2020-05-05
Firm location: Norwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K130917 — HEALIX ADVANCE KNOTLESS BR ANCHORDepuy Mitek, A Johnson & Johnson Company·cleared 2013-05-24

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.