FDA Device recall Z-2798-2020
Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniatio…
- FDA Device
- Class II
- terminated
- Published 2020-08-19
On 2020-08-19 the FDA classified a Class II recall of Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid¿ ACD is indicated for reducing the incidence of reherniatio… by Intrinsic Therapeutics, citing 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.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2798-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2020-07-24 |
| Published | 2020-08-19 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Intrinsic Therapeutics |
| Distribution | US |
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.
Identifiers
| code_info | Catalog #: BAR-A8-8MM Part #: 2730815-A8 Lot #: 06112001, 06152001 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2798-2020%22
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