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Sklar®
SKLAR CORPORATION · Model 20-9056 · UDI-DI 10649111372575
2
510(k) clearances
14
Adverse events
2
Recalls
115
Facilities
Description
NIRO WIRE TWISTING FCP 6"
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2012-08-28 | Kardium | The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use. |
| 2010-03-31 | KARDIUM INC. | A component of the device is installed incorrectly which can result in the component falling out of the device and into the patient during use. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.