On-X Life Technologies, Inc. recalls Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repai…

Recall date

December 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1057-2017

FDA classification

Class II

Brand / firm

On-X Life Technologies, Inc.

Sold / distributed

CA, WA, NE, DE, OH, ME, TX

Why it was recalled

Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed primary packages, 3) Loose hair was discovered within four sealed primary packages and 4) Assembly error, wherein Left and Right Housing components were acceptably press-fit together, was discovered within one sealed primary package. One of the Left Housing press-fit pins was not pressed into the associated hole of the Right Housing, resulting in a small gap in the housing assembly.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to repair the mitral valve and help the surgeon select a preconfigured prosthesis, or configure the correct size using straight suture material, during mitral valve repair.