Recall Z-1322-2024— Thommen Medical AG
Class II · Ongoing
Class II FDA medical device recall by Thommen Medical AG, initiated 2024-01-24. FDA's recall record names no specific 510(k) clearance for this event. Product: impression coping, repositionable, short, screw-retained, PF 4.0. Reason: The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant..
- Recalling firm
- Thommen Medical AG
- Classification
- Class II
- Status
- Ongoing
- Initiated
- 2024-01-24
- Firm location
- Bettlach, Switzerland
Product description
impression coping, repositionable, short, screw-retained, PF 4.0
Reason for recall
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Data sourced from openFDA. This site is unofficial and independent of the FDA.