FDAFDA · Food and drugs·Recall number Z-1175-2013
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.
Published May 1, 2013 · Recall initiated: March 22, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Distributor
- Nationwide Distribution.
- Lot
- ALL from Jan 1 2010 - Corrected IFU implementation date
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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