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DePuy Mitek, Inc., a Johnson & Johnson Co. recalls ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code: 223115. For use in
Recalled May 1, 2013 · FDA recall Z-1175-2013 · DePuy Mitek, Inc., a Johnson & Johnson
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 · FDA Class II
Units
46732
Sold at
Nationwide Distribution.
Description
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
Product
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.
Manufacturer(s)
DePuy Mitek, Inc., a Johnson & Johnson Co.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →