# FDA recall Z-0666-2020

> **DePuy Mitek, Inc., a Johnson & Johnson Co.** · Class II · device recall initiated 2019-11-04.

## Product

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.

## 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

## Key facts

- **Recall number:** Z-0666-2020
- **Recalling firm:** DePuy Mitek, Inc., a Johnson & Johnson Co.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2019-11-04
- **Report date:** 2019-12-18
- **Termination date:** 2020-05-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Norwood, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0666-2020

## Citation

> AI Analytics. FDA recall Z-0666-2020. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/Z-0666-2020. Source: US FDA. Licensed CC0.

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