FDA DeviceClass IINotable
FDA Recall: On-X Mitral Heart Valve with Conform-X Sewing Ring, Model: ONXMC-25/33
Description
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Hazard
Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
Remedy
10
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