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.
Enforcement
- Recall Number
- Z-2798-2020
- Event ID
- 86121
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Intrinsic Therapeutics, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- August 19, 2020
- Initiation Date
- July 24, 2020
- Classification Date
- August 13, 2020
- Termination Date
- September 16, 2020
- Address
- 30 Commerce Way, N/A, Woburn, MA, 01801-8503, United States
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.
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.
Catalog #: BAR-A8-8MM Part #: 2730815-A8 Lot #: 06112001, 06152001
US Nationwide distribution.
110 units