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U.S. Department of Health and Human Services

Enforcement Report - Week of May 1, 2013

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Product Detail

Product Description ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Recall Number Z-1174-2013
Classification Class II
Code Info ALL from Jan 1 2010 - Corrected IFU implementation date
Product Distributed Qty 206540
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 weeks after implantation.

Event Detail

Event Id 64706
Product Type Devices
Status Ongoing
Recalling Firm DePuy Mitek, Inc., a Johnson & Johnson Co.
City Raynham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-22
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution.