Woburn, MA, United States
Intrinsic Therapeutics, Inc. recalls
2 recalls recorded since 2018, most recently on 25 July 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 25 July 2024
- Reason
- At least two units have been found to be missing a weld.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2688-2024
- Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Terminated Class II Medical devices
- Recall started
- 24 July 2020
- Terminated
- 16 September 2020
- Reason
- 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.
- Distribution
- US Nationwide distribution.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-2798-2020
- 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 with
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.