Z-1680-2022 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2022
- Initiation Date
- July 26, 2022
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 4 devices
Product Description
Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Reason for Recall
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
Distribution Pattern
U.S.: AZ and FL O.U.S.: None
Code Information
Model Number: OPTI0520CSF10 UDI-DI Code: 00818053026164 Lot Number: F220600470