Twister, Wire
Orthopedic · 21 CFR 888.4540
Recent MDR events
14 adverse event reports on file
- INTEGRA® JARIT®Dec 8, 2025MalfunctionIntegra Lifesciences Production Corporation23735743
- MICROAIRE K-WIRESep 24, 2022InjuryMicroaire Surgical Instruments, Llc2020601-2022-00005
- MICROAIRE K-WIRESep 24, 2022InjuryMicroaire Surgical Instruments, Llc2020601-2022-00006
- ADAPT Ø2.8 F/LCP PAED-HIP PL3.5/5.0Apr 25, 2022MalfunctionSynthes Gmbh8030965-2022-02676
- INTEGRA JARITSep 8, 2021MalfunctionIntegra Lifesciences Production Corporation12438306
- WIRE TWSITERNov 15, 2016MalfunctionAlto Development Corp.6101842
- ADAPT Ø2.8 F/LCP PAED-HIP PL3.5/5.0Feb 22, 2013MalfunctionSynthes Gmbh8030965-2013-00611
- COMPR WIRE 1.6 L150/25Aug 28, 2012InjurySynthes Gmbh8030965-2012-00700
- CRIMPER F/TRANSV-ONNECTORSAug 15, 2012InjurySynthes Gmbh8030965-2012-00642
- WIREFeb 24, 2012MalfunctionSynthes (usa)2520274-2012-00290
Event type breakdown
Recalls
2 recall events for this product code
- KardiumTerminatedOct 11, 2012
TORQ Sternal Closure Device. The common name is TWISTER, WIRE. The model number is TQ01A.
The TORQ Sternal Closure Device, Lot 062711, is being recalled due to probability one of the metal parts may be dislodged during use.
Z-0054-2013 · View FDA record ↗ - KARDIUM INC.TerminatedJul 9, 2010
TORQ Sternal Closure Device, SINGLE-USE
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.
Z-1973-2010 · View FDA record ↗
Registered firms
117 firms currently registered for this product code
Heuer International (a Division Of Gst Corporation Limited)
NOIDA Uttar Pradesh, IN
Microport Orthopedics Inc.
Arlington, TN, US
Kls Martin Se & Co. Kg
Fridingen Baden-Wurttemberg, DE
Kls Martin Malaysia Sdn. Bhd.
Simpang Ampat Pulau Pinang, MY
Microport Orthopedics Global Supply Center Limited
Shanghai, CN
G. Hipp & Sohn Gmbh
NEUHAUSEN Baden-Wurttemberg, DE
Synthes Gmbh
Zuchwil Solothurn, CH
Xinhua Healthcare Industry Co.,limited
Zibo Shandong, CN
Smith & Nephew, Inc.
MEMPHIS, TN, US
Dufner Instrumente Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Suban Instruments Germany Gmbh
TUTTLINGEN Baden-Wurttemberg, DE
Arthrex Manufacturing Inc.
Pendleton, SC, US
Teleflex Llc (nadc)
Olive Branch, MS, US
Ambler Surgical, Llc
EXTON, PA, US
Aesculap Ag
TUTTLINGEN, DONAU Baden-Wurttemberg, DE
Shanghai Medical Instruments (group) Ltd. Corp.
Shanghai, CN
Bradshaw Medical Inc.
Kenosha, WI, US
Wexler Surgical, Inc.
HOUSTON, TX, US
Tecomet, Inc.
KENOSHA, WI, US
Adler Instrument Company
Brooksville, FL, US
Fetzer Medical Gmbh & Co.kg
Tuttlingen Baden-Wurttemberg, DE
Alframed
Sialkot Punjab, PK
Ortho-med, Inc.
Tigard, OR, US
Emerald Instruments
SIALKOT Punjab, PK
Ulrich Ag
ST. GALLEN Sankt Gallen, CH
510(k) clearances
2 clearances for this product code