Tong, Skull For Traction
Neurology · 21 CFR 882.5960
Recent MDR events
26 adverse event reports on file
- RESOLVE HALOApr 15, 2020InjuryOssur Americas0001836248-2020-00002
- POWERPUMP DAY CASSETTE 10PKFeb 10, 2017MalfunctionBiomet Sports Medicine0001825034-2017-00402
- GARDNER-WELLS TONGSep 9, 2016MalfunctionSymmetry Surgical, Inc.5938789
- MAYFIELD DISPOSABLE SKULL PINSJun 10, 2015Integra Lifesciences Corporation4840218
- GARDNER-WELLS TRACTION TONGS COMPLETEDec 2, 2011Carefusion1423507-2011-00019
- BREMER 3D CROWN SYSTEMMar 16, 2011InjuryDepuy Spine, Inc.1526439-2011-00039
- BREMER HALO 3D CROWNMay 25, 2010InjuryDepuy Spine, Inc.1526439-2010-00075
- BREMER 3D HALO CROWN SYSTEMDec 23, 2008InjuryDepuy Spine, Inc.1526439-2008-00212
- CODMAN SKULL TONGSep 22, 2006InjuryCodman & Shurtleff, Inc.1226348-2006-00254
- HIFIX SKULL PINDec 27, 2005MalfunctionDepuy Spine, Inc.1526439-2005-00279
Event type breakdown
Recalls
13 recall events for this product code
- Instrumed International, Inc.TerminatedDec 16, 2014
Gardner-Wells traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) and sold und
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Z-0550-2015 · View FDA record ↗ - Instrumed International, Inc.TerminatedDec 16, 2014
Replacement screw non-springloaded traction tongs are skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or disl
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Z-0551-2015 · View FDA record ↗ - Instrumed International, Inc.TerminatedDec 16, 2014
Lock nuts for titanium traction tongs are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Z-0552-2015 · View FDA record ↗ - Instrumed International, Inc.TerminatedDec 16, 2014
Titanium fixation screws, springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture o
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Z-0553-2015 · View FDA record ↗ - Instrumed International, Inc.TerminatedDec 16, 2014
Traction tong replacement screws, non-springloaded are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g.
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Z-0554-2015 · View FDA record ↗ - Instrumed International, Inc.TerminatedDec 16, 2014
Gardner-Wells wrenches are used in traction skull tongs for traction used to immobilize a patient with a cervical spine injury (e.g., fracture or dislocation) a
The reason these devices are being withdrawn from the market by Instrumed is that Instrumed did not market these devices prior to September 26, 1976, and therefore, does not meet all FDA requirements to market the devices as "Pre-Amendment" devices.
Z-0555-2015 · View FDA record ↗ - Ossur Engineering, IncTerminatedJun 19, 2009
ReSolve Halo - Open Back Halo Ring, Model Number: 505300D
Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
Z-1507-2009 · View FDA record ↗ - Ossur Engineering, IncTerminatedJun 19, 2009
ReSolve Halo - Open Back Halo Ring, Model Number: 505400D
Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
Z-1508-2009 · View FDA record ↗ - Ossur Engineering, IncTerminatedJun 19, 2009
ReSolve Halo - Open Back Halo Ring, Model Number: 510400D
Ossur initiated the recall after their investigation of some complaints found that in some instances the ceramic pins are difficult to screw through the halo ring.
Z-1509-2009 · View FDA record ↗ - Ossur AmericasTerminatedUnknown
Ossur OB Resolve, Sterile,
Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line description on the titanium pin label mistakenly lists ceramic tip. The second line description should state titanium pin.
Z-0999-2019 · View FDA record ↗
Registered firms
14 firms currently registered for this product code
Rudolf Storz Gmbh
EMMINGEN Baden-Wurttemberg, DE
Depuy Spine, Inc.
RAYNHAM, MA, US
Pmt Corp.
CHANHASSEN, MN, US
Depuy Orthopaedics
BRIDGEWATER, MA, US
Isomedix Operations, Inc.
Minneapolis, MN, US
Aspen Surgical Products, Inc.
Caledonia, MI, US
Medos International Sarl
Le Locle Neuchatel, CH
Industrias Apson S.a De C.v
AGUA PRIETA Sonora, MX
510(k) clearances
20 clearances for this product code
- Pmt Corp.Jul 28, 2009
K090733 · PMT HALO SYSTEM
- Ossur Americans (Formerly the Jerome Group)May 25, 2007
K071173 · RESOLVE TONGS, SMALL/MEDIUM, RESOLVE TONGS, MEDIUM/LARGE, MODEL JT-200D, JT-100D
- Jerome MedicalAug 17, 2005
K051918 · RESOLVE OPEN BACK HALO RINGS
- The Jerome Group, Inc.Feb 21, 2003
K023959 · JEROME GLASS RING
- Spine WorksJul 9, 2001
K003662 · SPINE WORKS COLLAR
- Friddle'S Orthopedic Appliances, Inc.Feb 18, 1999
K980689 · FRIDDLE HALO SYSTEM, FRIDDLE MRI HALO SYSTEM
- Jerome MedicalDec 6, 1995
K930021 · J TONGS
- Ace Medical Co.Oct 12, 1995
K954069 · ACE CERVICAL TRACTION HALOZS, TONGS & PINS