Chord-X Chordal Sizer is designed to assist in determining the proper… — Class II medical device recall Z-1057-2017
Terminated recall by On-X Life Technologies, Inc., reported 2017-02-01, distributed in CA, DE, ME, NE, OH, TX, WA. Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Ri
| Recall number | Z-1057-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | On-X Life Technologies, Inc., Austin, TX, United States |
| Recall initiated | 2016-12-13 |
| Classified | 2017-01-20 |
| Reported by FDA | 2017-02-01 |
| Terminated | 2017-04-13 |
| Distributed | CA, DE, ME, NE, OH, TX, WA |
| Quantity | 45 units |
| Reason classes | specification failure |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1057-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.