DePuy Mitek, Inc., a Johnson & Johnson Co.: 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

Agency Publication Date: April 25, 2013

Affected Products

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

ALL from Jan 1 2010 - Corrected IFU implementation date

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.

ALL from Jan 1 2010 - Corrected IFU implementation date

Product: ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

ALL from Jan 1 2010 - Corrected IFU implementation date

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.

ALL from Jan 1 2010 - Corrected IFU implementation date

Product: 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.

ALL from Jan 1 2010 - Corrected IFU implementation date

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 64706

Status: Resolved

Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.

Manufactured In: United States

Units Affected: 5 products (65062; 84174; 206540; 46732; 46501)

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Sources: FDA iRES · Raw API Response

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Affected Products

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

ALL from Jan 1 2010 - Corrected IFU implementation date