Z-1057-2017 Class II Terminated
FDA device recall Z-1057-2017 was initiated by On-X Life Technologies, Inc. on December 13, 2016 and is designated Class II. 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 pr… The recall status is terminated (terminated April 13, 2017). Affected quantity: 45 units.
Recall Details
- Product Type
- Devices
- Report Date
- February 1, 2017
- Initiation Date
- December 13, 2016
- Termination Date
- April 13, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 45 units
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.
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.
Distribution Pattern
CA, WA, NE, DE, OH, ME, TX
Code Information
72-00-47420