FDA recall Z-2052-2020

Product

Conformable Thoracic Stent Graft, Rx only, Sterile EO - Product Usage: This device is intended for endovascular repair of lesions of the descending thoracic aorta.

Reason for recall

The incorrect label was placed on both the primary and secondary package.

Distribution

International the country of Japan.

Key facts

Status

Terminated

Initiation date

2019-12-17

Report date

2020-05-27

Termination date

2021-04-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

Flagstaff, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2052-2020