Class II — Intrinsic Therapeutics, Inc.
| Recalling firm | Intrinsic Therapeutics Inc. |
|---|---|
| Registered facility | Intrinsic Therapeutics, Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| 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. |
| 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 an… |
| Quantity | 110 units |
| Distribution | US Nationwide distribution. |
| Initiated | 2020-07-24 |
| Classified | 2020-08-13 |
| Terminated | 2020-09-16 |
| Recall number | Z-2798-2020 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Intrinsic Therapeutics, Inc. (Z-2798-2020).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/86121/
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