Mosaic 310 Bioprosthesis, Mitral, REF 310C31 - Product Usage: Replacement of malfunctioning native or prosthetic aortic and/or mitral valves.

Reason: Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.

Code information: GTIN: 00643169594869 Serial Number: B804937

Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of TN, NY, NJ, and countries of France, Italy, Libya, Poland, Spain.