Intrinsic Therapeutics Recalls

Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A

Class I - Dangerous

At least two units have been found to be missing a weld.

Jul 25, 2024 Other Medical Devices Nationwide View Details →

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.

Class I - Dangerous

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.

Jul 24, 2020 Diagnostic Equipment Nationwide View Details →