Warning
On-X Life Technologies Recalls On-X Mitral Heart Valve with Conform-X Sewing Ring
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #Z-2133-2026Medical Device
On-X Life Technologies Recalls On-X Mitral Heart Valve with Conform-X Sewing Ring
On-X Life Technologies, Inc. · Class II — Moderate Risk
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.
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
International distribution to the country of South Korea.
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
Sources: FDA openFDA Enforcement Database