Kardium
Kardium appears in FDA public data with 1 recall, 2 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-0054-2013, Class II) was initiated on August 28, 2012. Its most recent 510(k) clearance was granted on June 25, 2025.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 2
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-0054-2013 | Class II | TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The | August 28, 2012 |