Intrinsic Therapeutics, Inc.: Device Recall

Recall #Z-2688-2024 · 07/25/2024

Class II: Risk

Recall Details

Recall Number
Z-2688-2024
Classification
Class II
Product Type
Device
Recalling Firm
Intrinsic Therapeutics, Inc.
Status
Ongoing
Date Initiated
07/25/2024
Location
Woburn, MA, United States
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
207 units

Reason for Recall

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

Product Description

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

Distribution Pattern

US Nationwide distribution.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.