FDAFDA · Food and drugs·Recall number Z-1322-2024
impression coping, repositionable, short, screw-retained, PF 4.0
Published March 27, 2024 · Recall initiated: January 24, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Thommen Medical AG
- Distributor
- US Nationwide distribution in the states of OH and KY.
- Lot
- Article No. 3.03.079; UDI/DI: 07640156475463; Lot No. 30972.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Switzerland
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