Z-2052-2020 Class II Terminated
FDA device recall Z-2052-2020 was initiated by W L Gore & Associates, Inc. on December 17, 2019 and is designated Class II. Reason for recall: The incorrect label was placed on both the primary and secondary package. The recall status is terminated (terminated April 28, 2021). Affected quantity: 15 stents.
Recall Details
- Product Type
- Devices
- Report Date
- May 27, 2020
- Initiation Date
- December 17, 2019
- Termination Date
- April 28, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 15 stents
Product Description
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 Pattern
International the country of Japan.
Code Information
Part number of the device is TGM343420J Serial numbers: 21225065 21225066 21225067 21225068 21225069 21225070 21225071 21225072 21225073 21225074 21225075 21225076 21225077 21225078 21225079 21225080 21225081 21225082 21225083 21225084