Reported Feb 1, 2017 · Terminated
Chord-X Chordal Sizer is designed to assist in determining the proper length of chordal replacement prostheses to…
On-X Life Technologies, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: On-X Life Technologies, Inc. · 1300 E Anderson Ln Ste B · Austin, TX · 78752-1739
Is this the product you have?
- 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.
- Lot codes and dates
- 72-00-47420
- Amount recalled
- 45 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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