On-X Life Technologies, Inc.: Medical Device Recall in 2017 - (Recall #: Z-1057-2017)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2017.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 13, 2016

Date Posted: February 1, 2017

Recall Number: Z-1057-2017

Event ID: 75951

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.

Status: Terminated

Product Quantity: 45 units

Code Information:

72-00-47420

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated