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.
Enforcement
- Recall Number
- Z-1057-2017
- Event ID
- 75951
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- On-X Life Technologies, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 1, 2017
- Initiation Date
- December 13, 2016
- Classification Date
- January 20, 2017
- Termination Date
- April 13, 2017
- Address
- 1300 E Anderson Ln Ste B, N/A, Austin, TX, 78752-1739, United States
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.
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.
72-00-47420
CA, WA, NE, DE, OH, ME, TX
45 units