Device product
ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223113. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Z-1173-2013
Product summary
- Event
- Event 64706
- Status
- Terminated
- Classification
- Class II
- Quantity
- 84174
- Official record key
device-enforcement:Z-1173-2013
Official wording
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
Code information: ALL from Jan 1 2010 - Corrected IFU implementation date
Distribution pattern: Nationwide Distribution.
Derived failure modes
-
Unknown
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