# FDA recall Z-2798-2020

> **Intrinsic Therapeutics, Inc.** · Class II · device recall initiated 2020-07-24.

## 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 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.

## Distribution

US Nationwide distribution.

## Key facts

- **Recall number:** Z-2798-2020
- **Recalling firm:** Intrinsic Therapeutics, Inc.
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2020-07-24
- **Report date:** 2020-08-19
- **Termination date:** 2020-09-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Woburn, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2798-2020

## Citation

> AI Analytics. FDA recall Z-2798-2020. Retrieved 2026-07-06 from https://api.ai-analytics.org/recall/Z-2798-2020. Source: US FDA. Licensed CC0.

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