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Terminated

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.

FDA Recall Z-2798-2020 · Posted None

Recalling FirmIntrinsic Therapeutics, Inc.
Recall StatusTerminated
Product CodeQES
Date Initiated2020-07-24
Date Terminated2020-09-16
Product Quantity110 units

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.

Firm 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.

Root Cause

Process control

Distribution Pattern

US Nationwide distribution.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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