On-X Life Technologies, Inc.: 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.

Recall number

Z-1057-2017

Recalling firm

On-X Life Technologies, Inc.

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.

Status

Terminated

Initiated

2016-12-13

Posted

2017-01-20

Terminated

2017-04-13

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.

Root cause

Component design/selection

Action

A letter was sent to the implanting surgerons notifyijng them of the recall and attemmpting retrieval.

Quantity

45 units

Distribution

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

Lot, serial or model codes

72-00-47420

510(k) numbers

["K141060"]

PMA numbers

not on file

Product code

PAW

Firm FEI

3001584317

Firm city

Austin

Firm state

TX

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

Copy