Class II
Medical Device Recall: impression coping, repositionable, short, screw-retained, PF 4.0
Thommen Medical AG · January 24, 2024
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.
Distribution
US Nationwide distribution in the states of OH and KY.
States Affected
NATIONWIDE
Quantity Affected
20 units
Source: FDA (openFDA Device Enforcement)
Recall number: Z-1322-2024
Status: ongoing
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