ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
This recall has been terminated (originally issued April 25, 2013).
- Recall Initiated
- March 22, 2013
- Posted
- April 25, 2013
- Terminated
- February 24, 2014
- Recall Number
- Z-1172-2013
- Quantity
- 65062
- Firm Location
- Raynham, MA
- Official Source
- View on FDA website ↗
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
Distribution
Nationwide Distribution.
Lot / Code Info
ALL from Jan 1 2010 - Corrected IFU implementation date
Root Cause
Labeling Change Control
Action Taken
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.