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U.S. Department of Health and Human Services

Class 2 Device Recall ChordX Chordal Sizer

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  Class 2 Device Recall ChordX Chordal Sizer see related information
Date Initiated by Firm December 13, 2016
Date Posted January 20, 2017
Recall Status1 Terminated 3 on April 13, 2017
Recall Number Z-1057-2017
Recall Event ID 75951
510(K)Number K141060  
Product Classification Nonabsorbable expanded polytetrafluoroethylene surgical suture for chordae tendinae repair or replac - Product Code PAW
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.
Code Information 72-00-47420
Recalling Firm/
Manufacturer		 On-X Life Technologies, Inc.
1300 E Anderson Ln Ste B
Austin TX 78752-1739
For Additional Information Contact Field Assurance
800-438-8285
Manufacturer 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.
FDA Determined
Cause 2		 Component design/selection
Action A letter was sent to the implanting surgerons notifyijng them of the recall and attemmpting retrieval.
Quantity in Commerce 45 units
Distribution CA, WA, NE, DE, OH, ME, TX
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = PAW and Original Applicant = ON-X LIFE TECHNOLOGIES, INC.
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