Alloy, Amalgam
FDA adverse event reports and recall history for alloy, amalgam (product code EJJ), from the public MAUDE/AEMS corpus and the live FDA recall database.
- Total reports
- 161
- Deaths
- 1
- Injuries
- 128
- Malfunctions
- 5
Reports per year
Source: FDA adverse event reports by year received, 2006–2021. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Recent recalls
- 2024-02-07Open, ClassifiedEmployee error
Article No. NA6050411, Valiant PhD No. 1 Econo
Affected product may not perform as expected; the amalgam powder may not triturate correctly and the physical properties (i.e. strength, compression, working time, etc.) will be adversely affected.
- 2014-06-13TerminatedUnknown/Undetermined by firm
Tytin Regular Set, Double Spill, 50 Capsules, Part Number 29948, Lot Number 3-1294. The intended use of this device is to be used as a dental restorative material in the treatment of dental caries.
Kerr Corporation is recalling one (1) lot of Tytin Regular Set ( Part Number 29948, Lot Number 3-1294), because it may set faster than specified in the Directions for Use.
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