Z-2798-2020Class II

Barricaid Annual Closure Device (ACD) BAR-A8-8MM -

Name: Z-2798-2020 Barricaid Annual Closure Device (ACD) BAR-A8-8MM -
Creator: Intrinsic Therapeutics, Inc.
Published: 2020-07-24
License: https://open.fda.gov/license/

Intrinsic Therapeutics, Inc. / initiated 2020-07-24 / Terminated / root cause: manufacturing process

FDA source

Intrinsic Therapeutics, Inc. began a recall of Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product Usage: The Barricaid ACD is indicated for reducing the incidence of reherniation, and reoperation in... on 2020-07-24. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2798-2020
Classification: Class II
Status: Terminated
Initiated: 2020-07-24
Posted: 2020-08-13
Terminated: 2020-09-16
Recalling firm: Intrinsic Therapeutics, Inc.
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.
Product code: QES Reherniation Reduction Device
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.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Intrinsic Therapeutics will be sending out a recall letter to all effected customers explaining the incorrect catalog number on the peelable inner label. The firm is requesting customers to quarantine any unused devices and return the completed recall acknowledgment form.
Quantity in commerce: 110 units
Distribution: US Nationwide distribution.
Product codes and lots: Catalog #: BAR-A8-8MM Part #: 2730815-A8 Lot #: 06112001, 06152001

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2798-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2798-2020	Class II	Terminated	Voluntary: Firm initiated	2020-08-19	2020-08-13

Product code QES

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)