Reported Mar 27, 2024 · Ongoing
impression coping, repositionable, short, screw-retained, PF 4.0
Thommen Medical AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Thommen Medical AG · Eschenweg 3 · Bettlach · N/A
Is this the product you have?
- impression coping, repositionable, short, screw-retained, PF 4.0
- Lot codes and dates
- Article No. 3.03.079
- UDI/DI
07640156475463Lot No. 30972
- Amount recalled
- 20 units
Where it was sold
Why it was recalled
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
This product could cause temporary or reversible health problems — stop using it.
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