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.
Recall
- Recall Number
- Z-2798-2020
- Event Number
- 86121
- Firm
- Intrinsic Therapeutics, Inc.
- FEI Number
- 3006232063
- Product Code
- QES
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- July 24, 2020
- Terminated
- September 16, 2020
- Address
- 30 Commerce Way, Woburn, MA, 01801-8503
Description
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.
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.
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.
US Nationwide distribution.
110 units