PlainRecalls
FDA Devices Moderate Class II Terminated

ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

Reported: May 1, 2013 Initiated: March 22, 2013 #Z-1172-2013

Product Description

ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

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

Details

Units Affected
65062
Distribution
Nationwide Distribution.
Location
Raynham, MA

Frequently Asked Questions

What product was recalled?
ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.. Recalled by DePuy Mitek, Inc., a Johnson & Johnson Co.. Units affected: 65062.
Why was this product recalled?
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
Which agency issued this recall?
This recall was issued by the FDA Devices on May 1, 2013. Severity: Moderate. Recall number: Z-1172-2013.