Device product
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Z-2133-2026
Product summary
- Event
- Event 98548
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10
- Official record key
device-enforcement:Z-2133-2026
Official wording
Reason: Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Code information: UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
Distribution pattern: International distribution to the country of South Korea.
Derived failure modes
-
Unknown
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.