FDA recall Z-0666-2020

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

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

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