DePuy Mitek, Inc., a Johnson & Johnson Co.: Healix Knotless ADV BR 5.5 Suture Anchor

Is my product affected?

Healix Knotless ADV BR 5.5 Suture Anchor

• UPC 10886705023479

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

What happened

DePuy Mitek, Inc., a Johnson & Johnson company, recalled 599 units of Healix Knotless ADV BR 5.5 Suture Anchors with specific lot and batch numbers. The recalled product was manufactured with BIOCRYL Biocomposite Material instead of the intended BIOCRYL RAPIDE Biocomposite Material. Both materials are biocompatible and effective for absorbable, injection-molded sports medicine implant fixation. The affected product codes are Part Number 222331 with Batch/Lot numbers 5L45259 and 5L13543, and the product was distributed across multiple states in the United States and internationally to countries including Belgium, Chile, China, France, Japan, Korea, and Sweden.

The recall notice does not specify a remedy or recommended action for affected consumers.

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: 599 Lot/code info: Part Number: 222331 Batch/Lot: 5L45259, 5L13543 GTIN: 10886705023479

Source

Official record: FDA (Device enforcement) ↗

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

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