Date Initiated by Firm | March 22, 2013 |
Date Posted | April 25, 2013 |
Recall Status1 |
Terminated 3 on February 24, 2014 |
Recall Number | Z-1175-2013 |
Recall Event ID |
64706 |
510(K)Number | K043298 |
Product Classification |
Suture, surgical, absorbable, polydioxanone - Product Code NEW
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Product | ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115.
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
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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 | 46732 |
Distribution | Nationwide Distribution. |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = NEW
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