Z-1057-2017Class II

Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement...

Name: Z-1057-2017 Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement...
Creator: On-X Life Technologies, Inc.
Published: 2016-12-13
License: https://open.fda.gov/license/

On-X Life Technologies Inc. / initiated 2016-12-13 / Terminated / root cause: design

FDA source

On-X Life Technologies, Inc. began a recall of 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... on 2016-12-13. FDA classified it as Class II and gives the reason as "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)...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1057-2017
Classification: Class II
Status: Terminated
Initiated: 2016-12-13
Posted: 2017-01-20
Terminated: 2017-04-13
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.
Product code: PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
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.
Root cause tag: design
FDA root cause: Component design/selection
Action: A letter was sent to the implanting surgerons notifyijng them of the recall and attemmpting retrieval.
Quantity in commerce: 45 units
Distribution: CA, WA, NE, DE, OH, ME, TX
Product codes and lots: 72-00-47420

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1057-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1057-2017	Class II	Terminated	Voluntary: Firm initiated	2017-02-01	2017-01-20

Product code PAW

K141060Class IIChord-X Pre-Measured Loops for Mitral Chordal ReplacementOn-X Life Technologies, Inc. / cleared 2014-06-06

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)