Device 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.
Z-2798-2020
Product summary
- Event
- Event 86121
- Status
- Terminated
- Classification
- Class II
- Quantity
- 110 units
- Official record key
device-enforcement:Z-2798-2020
Official wording
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.
Code information: Catalog #: BAR-A8-8MM Part #: 2730815-A8 Lot #: 06112001, 06152001
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
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.