Z-2133-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- May 20, 2026
- Initiation Date
- February 1, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10
Product Description
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Reason for Recall
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Distribution Pattern
International distribution to the country of South Korea.
Code Information
UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17