Class II — Potential Health Hazard

Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Healix Knotless ADV BR 5.5 Suture Anchor Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. Due to Specific product codes and lots of the Mitek...

Date: November 4, 2019
Company: DePuy Mitek, Inc., a Johnson & Johnson Co.
Status: Terminated
Source: FDA (Device)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact DePuy Mitek, Inc., a Johnson & Johnson Co. directly.

Affected Products

Healix Knotless ADV BR 5.5 Suture Anchor

Quantity: 599

Why Was This Recalled?

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.

Where Was This Sold?

This product was distributed to 29 states: AL, AZ, CA, CT, FL, IL, IN, IA, LA, ME, MD, MA, MI, MN, MT, NE, NH, NJ, NM, NC, OH, OK, OR, PA, TN, TX, VA, WA, WI

Affected (29 states)Not affected

About DePuy Mitek, Inc., a Johnson & Johnson Co.

DePuy Mitek, Inc., a Johnson & Johnson Co. has 51 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Device). Last updated March 26, 2026. View original report