FDA recall Z-2688-2024
Intrinsic Therapeutics, Inc. · Class II · device
Product
Barricaid Annular Closure Impactor, REF: BAR-IMPACTOR, P/N: 400906-A
Reason for recall
At least two units have been found to be missing a weld.
Distribution
US Nationwide distribution.
Key facts
- Status
- Ongoing
- Initiation date
- 2024-07-25
- Report date
- 2024-08-28
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Woburn, MA, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2688-2024