[Recalled] Healix Knotless ADV BR 4.75 Suture Anchor — Specific product codes and lots of the Mitek HEALIX ADVANCE" Knotless Anchors w… | FDA 2019-11-04

Regulators flagged this product in an official safety action. Here is what the notice says and what it means for owners.

Recall details

Why it was recalled

According to the FDA_DEVICE notice, the identified hazard is: 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.

This Class II recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.

What to do if you own this product

Check whether your unit is affected and follow the authority's guidance before further use.

Read the full official notice →

Related recalls from DePuy Mitek, Inc., a Johnson & Johnson Co.

• SpiraLok 6.5mm with Ethibond and needles Product Number: 222962 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow — Class II
• ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. — Class II
• Depuy Spine Side Fire Needles 11G X 6IN Side-Fire Needle, part of the Confidence Spinal Cement System Product Code 283904611. The Confidence Side Fire Needle is used to place bone cement in an intra-vertebral fashion at a desired location. the cement extrudes fro the needle through a port on th — Class II
• ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures. — Class II
• SpiraLok 6.5mm with Ethibond without needles Product Number: 222966 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow — Class II
• SpiraLok 5.0 w/out Needles with violet and blue Orthocord Product Number: 222986 SPIRALOK Anchors are primarily used to re-attach soft tissue to bone in rotator-cuff repair surgery, but are also indicated for use in the foot/ankle, knee and elbow — Class II

This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.