Class II — Kardium
| Recalling firm | Kardium Inc. |
|---|---|
| Registered facility | KARDIUM Inc. (the firm's only registered facility) |
| Classification | Class II |
| Status | Terminated |
| Reason | The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use. |
| Product | 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, 15-00001 (or 17-00002): TORQ Sternal Closure Device 10-pack - Sterile. The device is supplied double-pouched, inside a shelf box containing 10 devices each. Shelf boxes are shipped to customers in either a small shipping carton containing one (1) shelf box (for a total of 10 devices), or large shipping carton containing six (6) shelf boxes (for a total of 6 x 10 = 60 devices). This prod… |
| Quantity | 480 units |
| Distribution | Nationwide Distribution-including the states of FL, GA, IL, and NH. |
| Initiated | 2012-08-28 |
| Classified | 2012-10-11 |
| Terminated | 2013-02-05 |
| Recall number | Z-0054-2013 |
| Initiation | Voluntary: Firm initiated |
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this recall record at FDA → (opens in a new tab)
Cite this record
RegWarden. “Class II recall — Kardium (Z-0054-2013).” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/recall/63111/
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