Instruments, Dental Hand
FDA adverse event reports and recall history for instruments, dental hand (product code DZN), from the public MAUDE corpus and the live FDA recall database.
- Total reports
- 656
- Deaths
- 0
- Injuries
- 42
- Malfunctions
- 609
Reports per year
Source: FDA adverse event reports by year received, 2011–2026. Reporting paused twice in 2026 during FDA reporting-system changes and has since resumed.
Recent recalls
- 2012-11-05TerminatedError in labeling
Vector TAS Modular Driver, a manual driver for Vector TAS dental screws.
The Instructions For Use (IFUs) for Vector TAS Modular Driver for some foreign language sections incorrectly lists the sterilization temperature as 130C. The correct sterilization temperature should be listed as 132C and/or 270F.
- TerminatedNonconforming Material/Component
InterGuard 5.5mm Econo Refill, sizes, 4.0mm for short anatomical crowns and 5.5mm, part # 4012 Product Usage: InterGuard is a preventive aid for operative dentistry. It is used to protect adjacent teeth from iatrogenic preparation damage. This includes cavity and tunnel preparations as well as air abrasion.
Ultradent is recalling InterGuard 5.5mm Econo Refill, lot#s BC2GN and BC4L7 because product was received from the supplier with the floss tether hole not completely punched through and were distributed.
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