PlainRecalls
FDA Devices Moderate Class II Ongoing

impression coping, repositionable, short, screw-retained, PF 4.0

Reported: March 27, 2024 Initiated: January 24, 2024 #Z-1322-2024

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.

Details

Recalling Firm
Thommen Medical AG
Units Affected
20 units
Distribution
US Nationwide distribution in the states of OH and KY.
Location
Bettlach

Frequently Asked Questions

What product was recalled?
impression coping, repositionable, short, screw-retained, PF 4.0. Recalled by Thommen Medical AG. Units affected: 20 units.
Why was this product recalled?
The depth of the internal canal was not manufactured according to specifications. Thus, the impression coping cannot be firmly connected to the implant.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 27, 2024. Severity: Moderate. Recall number: Z-1322-2024.