Recall Z-2798-2020— Intrinsic Therapeutics, Inc.

Name: FDA recall Z-2798-2020
Creator: U.S. Food and Drug Administration
Published: 2020-07-24

Class II · Terminated

Class II FDA medical device recall by Intrinsic Therapeutics, Inc., initiated 2020-07-24, terminated 2020-09-16. Product: 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.. Reason: 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..

Recalling firm: Intrinsic Therapeutics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-07-24
Terminated: 2020-09-16
Firm location: Woburn, MA, United States

Product 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.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.