Recall Z-1057-2017— On-X Life Technologies, Inc.

Name: FDA recall Z-1057-2017
Creator: U.S. Food and Drug Administration
Published: 2016-12-13

Class II · Terminated

Class II FDA medical device recall by On-X Life Technologies, Inc., initiated 2016-12-13, terminated 2017-04-13. It names one FDA 510(k) clearance: K141060. Product: 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: 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.
Classification: Class II
Status: Terminated
Initiated: 2016-12-13
Terminated: 2017-04-13
Firm location: Austin, TX, United States

510(k) clearances named in this recall

1 on FDA's record

K141060 — CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENTOn-X Life Technologies, Inc.·cleared 2014-06-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.