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.
This recall has been terminated (originally issued July 24, 2020).
- Company
- Intrinsic Therapeutics, Inc.
- Recall Initiated
- July 24, 2020
- Terminated
- September 16, 2020
- Recall Number
- Z-2798-2020
- Quantity
- 110 units
- Firm Location
- Woburn, MA
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
Catalog #: BAR-A8-8MM Part #: 2730815-A8 Lot #: 06112001, 06152001
Root Cause
Process control
Action Taken
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.