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

Hazard

Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.

Details from the source

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: International distribution to the country of South Korea. Quantity: 10 Lot/code info: UDI-DI: 00851788001303. Serial Numbers: A2013401, A2013402, A2013403, A2013404, A2013405, A2013407, A2013408, A2013409, A2013410, A2013411. Expiration: 2031Dec17

UPC codes

00851788001303

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.