Bender
FDA adverse event reports and recall history for bender (product code HXW), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 320
- Deaths
- 0
- Injuries
- 22
- Malfunctions
- 297
Reports per year
Source: FDA adverse event reports by year received, 2012–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2015-01-28TerminatedFinished device change control
2.0 Mandible Locking Plate (MLP) Bender / Cutter (part number 329.143) Intended to be used for bending and/or cutting Mandible Locking Plates.
Certain lots have the potential for tip breakage while bending 2.0 mm thick plates. If device is used and breaks while in the Operating Room, surgical delay may occur while alternate bending or cutting instruments are located.
- TerminatedDevice Design
RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Customized coronal rod benders may deform the implant when used with the spinal system devices.
- TerminatedDevice Design
LEFT CORONAL BENDER, TEK1939. Instrument used during spinal surgery.
Customized coronal rod benders may deform the implant when used with the spinal system devices.
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