Bettlach, N/A, Switzerland
Thommen Medical AG recalls
2 recalls recorded since 2018, most recently on 24 January 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 24 January 2024
- Reason
- The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
- Distribution
- US Nationwide distribution in the states of OH and KY.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1322-2024
- impression coping, repositionable, short, screw-retained, PF 4.0
Terminated Class II Medical devices
- Recall started
- 3 April 2019
- Terminated
- 12 August 2019
- Reason
- 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).
- Distribution
- US Nationwide distribution in the state of OH.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1390-2019
- 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 th
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.