Reported May 1, 2013 · Terminated
ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles, Catalog Number: 223114. For use in…
DePuy Mitek, Inc., a Johnson & Johnson Co.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DePuy Mitek, Inc., a Johnson & Johnson Co. · 325 Paramount Drive · Raynham, MA · 02767-5199
Is this the product you have?
- ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-7 Taper Needles
- Catalog Number223114. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures
- Lot codes and dates
- ALL from Jan 1 2010 - Corrected IFU implementation date
- Amount recalled
- 206540
This recall covers 5 products
The agency filed one notice per product. You are reading one of them; the other 4 are below.
Where it was sold
- Nationwide
Why it was 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
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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