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Chord-X Chordal Sizer is designed to assist in determining… recallZ-1057-2017 · On-X Life Technologies, Inc. · initiated Dec 13, 2016

Class II Terminated All recalls posted in January 2017

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from On-X Life Technologies, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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.

FDA root cause category: Component design/selection

What the company is doing

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

Recall details

Recall number
Z-1057-2017
Recall class
Class II
Status
Terminated
Initiated by the company
Dec 13, 2016
Posted by the FDA
Jan 20, 2017
Recalling firm
On-X Life Technologies, Inc.
Quantity
45 units
Product code
PAW
FDA submissions
K141060
Distribution
CA, WA, NE, DE, OH, ME, TX

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.

Code information (models, lots, serial numbers)

72-00-47420

Other devices under the same FDA submission

3 devices cleared under K141060 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

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