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U.S. Department of Health and Human Services

Class 2 Device Recall Barricaid Annular Closure Device (ACD)

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 Class 2 Device Recall Barricaid Annular Closure Device (ACD)see related information
Date Initiated by FirmJuly 24, 2020
Create DateAugust 13, 2020
Recall Status1 Terminated 3 on September 16, 2020
Recall NumberZ-2798-2020
Recall Event ID 86121
PMA NumberP160050 
Product Classification Reherniation reduction device - Product Code QES
ProductBarricaid 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.
Code Information Catalog #: BAR-A8-8MM Part #: 2730815-A8 Lot #: 06112001, 06152001
FEI Number 3006232063
Recalling Firm/
Manufacturer		 Intrinsic Therapeutics, Inc.
30 Commerce Way
Woburn MA 01801-8503
For Additional Information ContactSamir Paliwal
781-932-0222 Ext. 101
Manufacturer 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.
FDA Determined
Cause 2		Process control
ActionIntrinsic 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 Commerce110 units
DistributionUS Nationwide distribution.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 �7.55.
PMA DatabasePMAs with Product Code = QES
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