Recall Z-1176-2013 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
DePuy Mitek, Inc., a Johnson & Johnson Co.
ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
| Date | Apr 25, 2013 (initiated Mar 22, 2013) |
| Status | Terminated |
| Reason | 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 |
| Root cause | 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 |
| Quantity | 46501 |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K043298 | BLUE ORTHOCORD SUTURE Depuy Mitek, Dec 10, 2004 |