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Axel Wire Twister/Cutter

SONTEC INSTRUMENTS, INC. · Model 1103-155H · UDI-DI 00192896116887

HXS Prescription
2
510(k) clearances
14
Adverse events
2
Recalls
115
Facilities

Description

Axel Wire Twister/Cutter With Hole Needle Holder Style Heavy Jaw

Recalls

DateFirmReason
2012-08-28KardiumThe TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use.
2010-03-31KARDIUM 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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Data 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.