Recall Z-1057-2017 ยท PAW Nonabsorbable Expanded Polytetrafluoroethylene Surgical Suture For Chordae Tendinae Repair Or Replacement
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.
| Date | Jan 20, 2017 (initiated Dec 13, 2016) |
| Status | Terminated |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141060 | CHORD-X PRE-MEASURED LOOPS FOR MITRAL CHORDAL REPLACEMENT On-X Life Technologies, Inc., Jun 6, 2014 |