DePuy Mitek Recalls ORTHOCORD Sutures Due to Inaccurate Strength Labeling
DePuy Mitek is recalling ORTHOCORD sutures because the instructions for use incorrectly state that Blue sutures retain 100% strength at six weeks.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error regarding suture strength retention. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity labeling issue.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling ORTHOCORD One Violet and One Blue Braided Composite Sutures with MO-7 Taper Needles, Catalog Number 223114. The recall involves 206,540 units distributed nationwide.
The recall is due to an inaccuracy in the Instructions for Use (IFU). The current IFU states that approximately 100% suture strength remains at six weeks after implantation. While this is accurate for Violet ORTHOCORD sutures, it is inaccurate for Blue ORTHOCORD free strand sutures, which maintain approximately 80% of strength at six weeks based on in-vivo studies.
The affected units are all lots from January 1, 2010, through the corrected IFU implementation date. Healthcare providers and facilities should stop using the affected Blue ORTHOCORD sutures and contact DePuy Mitek for instructions on returning the product.
The recalled product
- 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.
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 206,540
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- ALL from Jan 1 2010 - Corrected IFU implementation date
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by DePuy Mitek, Inc., a Johnson & Johnson Co. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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