Thommen Medical Ag
FDA adverse event reports naming Thommen Medical Ag as the device manufacturer, with recall history from the live FDA recall database. Reporter-supplied name as filed: THOMMEN MEDICAL AG.
- Total reports
- 20,826
- Deaths
- 1
- Injuries
- 20,820
- Malfunctions
- 3
Reports per year
Source: FDA adverse event reports by year received, 2018–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.
Top device categories
Recent recalls
- 2024-03-20Open, ClassifiedProcess change control
impression coping, repositionable, short, screw-retained, PF 4.0
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
- 2007-07-24TerminatedOther
SPI EASY Abutment. Endosseous dental implant abutment.
The undercut on the SPI EASY abutments which engages the stabilization ring of the implant is missing. Although the abutments can still be placed on the implant by the user the parts do not fulfill the quality expectations of the firm.
- TerminatedUnder Investigation by firm
Adapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - Product Usage: The adapter for handpiece, guided reusable, for guide sleeve 4.8 mm is used to transfer the implant from the packaging to the patient via a plug-in connection and screwed in manually or mechanically.
Dental adaptor does not conform to specifications. The dental coupling of the adapter can become deformed when being inserted into the implant may make it difficult to remove the adapter from its counterpart (e.g. the handpiece).
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