Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replaceme...
FDA Recall #Z-1057-2017 — Class II — December 13, 2016
Product Description
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.
Reason for Recall
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.
Recalling Firm
On-X Life Technologies, Inc. — Austin, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
45 units
Distribution
CA, WA, NE, DE, OH, ME, TX
Code Information
72-00-47420
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated