Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-1175-2013 — 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.

U.S. FDA — Device Enforcement · United States · 2013-03-22 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1175-2013
Date of alert: 2013-03-22
Country / jurisdiction: United States
Risk level: Class II
Risk type: recall
Brand: DePuy Mitek, Inc., a Johnson & Johnson Co.
Product category: device
Product type: Devices

Reported risk: 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

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

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ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-1175-2013 — 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.

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