DePuy Mitek, Inc., a Johnson & Johnson Co.: Healix Knotless ADV BR 4.75 Suture Anchor

Is my product affected?

Healix Knotless ADV BR 4.75 Suture Anchor

• UPC 10886705023462

Check against the official notice below — it lists the full affected range.

What happened

DePuy Mitek, Inc., a Johnson & Johnson company, recalled 299 units of Healix Knotless ADV BR 4.75 Suture Anchors (Part Number 222330, Lot 5L45257) because certain product codes and lots were manufactured with BIOCRYL Biocomposite Material instead of the intended BIOCRYL RAPIDE Biocomposite Material. These suture anchors are absorbable implants used in sports medicine procedures for fixation. The affected products were distributed across multiple U.S. states including Alabama, Arizona, California, Connecticut, Florida, and others, as well as internationally to countries including Belgium, Chile, China, France, Japan, Korea, and Sweden, among others.

Both BIOCRYL and BIOCRYL RAPIDE are biocompatible and effective biocomposite materials for absorbable, injection-molded sports medicine implant fixation. The source document does not specify a remedy for consumers or healthcare providers who may have received these products.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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 Quantity: 299 Lot/code info: Part Number: 222330 Batch/Lot: 5L45257 GTIN: 10886705023462

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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