Component, Traction, Invasive
FDA adverse event reports and recall history for component, traction, invasive (product code JEC), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 298
- Deaths
- 1
- Injuries
- 122
- Malfunctions
- 171
Reports per year
Source: FDA adverse event reports by year received, 2011–2025. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2010-03-16TerminatedProcess control
Stableloc (TM) Wrist External Fixation System, Quantity 1. Packaged labeled, "Stableloc Wrist Fixator System... Desc:stabeloc (TM) External Fixator Kit... Ref FX-4001-S... Manufactured or Distributed by: Acumed (R) 5885 NW Cornelius Pass Road, Hillsboro, OR 97124...STERILE"
Parts are non-functional. The user is unable to fully pass the fixator pins through the body of the Stableloc assembly as required. The kit may also be missing the set screw.
- 2008-09-16TerminatedDevice Design
Hoffman II compact Sterile Wrist Kit is used in the stabilization of open and unstable fractures.
Stryker Orthopaedics became aware that the pin of the Hoffmann II Compact External Fixation System may jam into the Soft Tissue protector.
- TerminatedUnder Investigation by firm
Agee-WristJack Fracture Reduction System; Item number: CFD-147. The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. This is a single use system used for a trauma related surgery The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures. The non-perishable sterile system is packaged in an inner then outer tray and shipped in a cardboard shelf box. Orthopedic:The WristJack Fracture Reduction System is a fracture reduction and external fixation system for treatment of distal radius fractures.
A number of Agee WristJack Fracture Reduction Systems have been manufactured with a molded beam slightly larger than optimal. This may result in the surgeon experiencing difficulty fine-tuning the length (red) and radial/ulnar alignment (blue) adjustments on the device.
- TerminatedUnder Investigation by firm
Stryker Pin To Rod Coupling External Fixation System Hoffmann II Compact - Pin To Rod Coupling 5/3-4mm Catalog #: 4940-1-020 - Product Usage: Indications Distal radius fractures (intra and extra) articular Intercarpal fracture dislocations Unstable forearm fractures Unstable elbow dislocation Multiple extremity fractures Radial osteotomies Foot and ankle fractures Paediatric fractures
Pin To Rod Coupling could not clamp the pin and rod as intended
- TerminatedLabeling design
Ossur Skull Pin, Sterile Titanium Pin, Part/Description: 516TS/ Skull Pin 2-1/4in TI Sterl 1PK; 516V2S/ Skull Pin 3in TI Sterl 1PK; 520TS/ Skull Pin 2-1/4in TI Sterl 5PK; 520V2S/ Skull Pin 3in TI Sterl 5 PK
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.
- TerminatedDevice Design
Anjon Bremer Molded Crown. bone fixation fastener for spinal use. REF number 100048 - Product Usage: Smooth or threaded metallic bone fixation fastener. Provides cervical spine immobilization and therapeutic traction for treatment of patients with cervical trauma or other neck conditions.
High rate of galling of one threaded component.
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