FDA Recalls Barricaid Annual Closure Devices Due to Labeling Error
Intrinsic Therapeutics is recalling 110 units of Barricaid Annual Closure Devices because the inner container labels display the wrong catalog number.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text identifies the issue as a labeling error (incorrect catalog number) without reporting any injuries, illnesses, or functional defects in the device itself. This aligns with the rubric for minor labeling errors.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for 110 units of the Barricaid Annual Closure Device (ACD) model BAR-A8-8MM. The recall was initiated by Intrinsic Therapeutics, Inc. due to a labeling error on the product's packaging.
The specific defect involves the peelable inner labels, also known as patient stickers, located on the inner container box. These labels incorrectly state the catalog number as BAR-A8-10MM instead of the correct BAR-A8-8MM. The affected units are identified by Catalog # BAR-A8-8MM, Part # 2730815-A8, and Lot # 06112001 or 06152001.
The Barricaid ACD is a medical device indicated for reducing the incidence of reherniation and reoperation in skeletally mature patients with radiculopathy attributed to a posterior or posterolateral herniation. The affected units were distributed nationwide in the United States. Healthcare providers and patients should verify the catalog number on the inner container label to ensure they are not using the mislabeled units.
The recalled product
- 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…
- Manufacturer
- Intrinsic Therapeutics, Inc.
- Category
- Medical Device — Spinal Implant
- Hazard
- Affected units
- 110
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog #: BAR-A8-8MM Part #: 2730815-A8 Lot #: 06112001
- 06152001
Distribution
Distributed nationwide across the United States.
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