FDA recall Z-1322-2024

Product

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.

Distribution

US Nationwide distribution in the states of OH and KY.

Key facts

Status

Ongoing

Initiation date

2024-01-24

Report date

2024-03-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bettlach, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1322-2024