Z-0126-2024 Class II
FDA device recall Z-0126-2024 was initiated by SynCardia Systems LLC on August 1, 2023 and is designated Class II. Reason for recall: Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy. Affected quantity: 114 units.
Recall Details
- Product Type
- Devices
- Report Date
- November 1, 2023
- Initiation Date
- August 1, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114 units
Product Description
SynCardia 50cc TAH-t, Clinical, REF 570500, Sterile EO
Reason for Recall
Artificial hearts contain a epoxy resin that has not been reviewed by the FDA for safety and efficacy.
Distribution Pattern
US: FL, WI, AZ, TX, CA, OH, NC, IN, OK, IL, VA, NY, NE, PA, WA, OUS: Saudi Arabia, Austria, Italy, Macedonia, Turkey, Germany, France, Kuwait, Serbia, United Kingdom, Canada, Lithuania, Slovenia Australia
Code Information
All Lots/ UDI: 00858000003053