🔍 RecallPedia

Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation, and confirmed by history, physical examination and imaging studies which demonstrate neural compression using MRI to treat a large annular defect (between 4-6 mm tall and between 6-10 mm wide) following a primary discectomy procedure (excision of herniated intervertebral disc) at a single level between L4 and S1.

Class I - Dangerous
🏥 Medical Devices Recalled: July 24, 2020 Intrinsic Therapeutics Diagnostic Equipment Nationwide

What Should You Do?

  1. Check if you have this product:
    Catalog #: BAR-A8-8MM Part #: 2730815-A8 Lot #: 06112001, 06152001
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Intrinsic Therapeutics, Inc.
Reason for Recall:
The catalog ( REF ) number on the peelable inner labels (patient sticker) that is on the inner container (box) is incorrect. It states BAR-A8-10MM instead of BAR-A8-8MM.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniation, and reoperation in skeletally mature patients with radiculopathy (with or without back pain) attributed to a posterior or posterolateral herniation, and confirmed by history, physical examination and imaging studies which demonstrate neural compression using MRI to treat a large annular defect (between 4-6 mm tall and between 6-10 mm wide) following a primary discectomy procedure (excision of herniated intervertebral disc) at a single level between L4 and S1.

Product Codes/Lot Numbers:

Catalog #: BAR-A8-8MM Part #: 2730815-A8 Lot #: 06112001, 06152001

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2798-2020

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