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On-X Life Technologies, Inc.: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33

Medical DevicesSource: FDA (device) · Date: 2026-05-20

Read the official notice at FDA (device) →

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
On-X Life Technologies, Inc.
Product
On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Reason / hazard
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Classification
Class II
Status
Ongoing
Distribution / sold at
International distribution to the country of South Korea.
Recall initiated
2026-02-01
Code info
UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17
Product quantity
10
Voluntary mandated
Voluntary: Firm initiated
City
Austin
State
TX
Country
United States
Event id
98548
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