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U.S. Department of Health and Human Services

Class 2 Device Recall ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2

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  Class 2 Device Recall ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 see related information
Date Initiated by Firm March 22, 2013
Date Posted April 25, 2013
Recall Status1 Terminated 3 on February 24, 2014
Recall Number Z-1172-2013
Recall Event ID 64706
510(K)Number K043298  
Product Classification Suture, surgical, absorbable, polydioxanone - Product Code NEW
Product ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111.

For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Code Information ALL from Jan 1 2010 - Corrected IFU implementation date
Recalling Firm/
Manufacturer		 DePuy Mitek, Inc., a Johnson & Johnson Co.
325 Paramount Drive
Raynham MA 02767-5199
For Additional Information Contact Sandra L. Gelinas
508-880-8100
Manufacturer Reason
for Recall		 The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six
FDA Determined
Cause 2		 Labeling Change Control
Action On March 22, 2013, firm notified consignees of recall via letter. Consignees were informed of the following: The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation. As Blue and Violet ORTHOCORD free strand sutures share the same IFU, IFU-108147 will be revised. Consignees were requested to confirm the receipt of the letter by March 29, 2013.
Quantity in Commerce 65062
Distribution Nationwide Distribution.
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 = NEW and Original Applicant = Depuy Mitek
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