Drug recall
TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers…
FDA recall event 63111 · Class II · Kardium
Key facts
| Event ID | 63111 |
|---|---|
| Recall numbers | Z-0054-2013 |
| Recalling firm | Kardium |
| Product type | Devices |
| Products | TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A. The Catalog numbers are: 17-00001: TORQ Sternal Closure Device Shipping Carton (6-10 packs), Sterile and… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use. |
| Initiation date | Aug 28, 2012 |
| Report date | Oct 17, 2012 |
| Termination date | Feb 5, 2013 |
| City | Richmond |
| Country | Canada |
| FEI number | 3009214225 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: