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Twister, Wire
FDA product code HXS · Class 1 · Orthopedic
220
Registered devices
14
Adverse events
2
Recalls
2
510(k) clearances
Devices with this code
FORCEPS — KLS-Martin L.P.uCentum — Ulrich GmbH & Co. KGgSource — GSOURCE LLCN/A — BIOMET MICROFIXATION, INCAxel Wire Twister/Cutter — SONTEC INSTRUMENTS, INC.KMEDIC — TELEFLEX INCORPORATEDgSource — GSOURCE LLCA&E Medical / Wire Twister — A & E MEDICAL CORPORATIONBOSS Instruments — BOSS INSTRUMENTS, LTD., INC.Malibu — Seaspine Orthopedics CorporationFORCEPS — KLS-Martin L.P.NewPort — Seaspine Orthopedics CorporationPILLING — TELEFLEX INCORPORATEDIntegra® Jarit® — INTEGRA LIFESCIENCES PRODUCTION CORPORATIONAXEL WIRE TWISTER — SONTEC INSTRUMENTS, INC.Malibu — Seaspine Orthopedics CorporationWire Twister — SONTEC INSTRUMENTS, INC.Valkyrie Wire Twister — SONTEC INSTRUMENTS, INC.CERCLAGE WIRE TWISTER — SONTEC INSTRUMENTS, INC.gSource — GSOURCE LLCDouble Wire Twister — JACE MEDICAL, LLCINKA — The Trustee for KAISER FAMILY TRUSTLOUTE WIRE TWISTER — SONTEC INSTRUMENTS, INC.Malibu — Seaspine Orthopedics Corporation
Recent 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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