medical Class II Updated 2020-08-19

Intrinsic Therapeutics, Inc. recalls Barricaid Annual Closure Device (ACD) BAR-A8-8MM - Product U

Recalled 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.


Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog #: BAR-A8-8MM Part #: 2730815-A8 Lot #: 06112001, 06152001
View official government recall

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