FDA-Device2024-03-27Class II
impression coping, repositionable, short, screw-retained, PF 4.0
Thommen Medical AG
Hazard
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Sold states
US Nationwide distribution in the states of OH and KY.
Affected count
20 units
Manufactured in
Eschenweg 3, Bettlach, Switzerland
Products
impression coping, repositionable, short, screw-retained, PF 4.0
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief