DePuy Mitek Recalls Blue Orthocord Sutures Due to Inaccurate Labeling
DePuy Mitek is recalling Blue Orthocord sutures because the instructions for use incorrectly state that 100% suture strength remains 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 65,062 units of ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number 223111. The product is used for general soft tissue approximation and ligation, including orthopedic procedures. The recall covers units distributed nationwide with a corrected IFU implementation date from January 1, 2010.
The recall was initiated because the Instructions for Use (IFU) provided with the free strand Blue ORTHOCORD sutures incorrectly indicate that approximately 100% suture strength remains at six weeks after implantation. While this statement is accurate for Violet ORTHOCORD sutures, in-vivo strength retention studies show that Blue ORTHOCORD sutures maintain approximately 80% of their strength at six weeks.
Healthcare providers and patients should verify the catalog number and color of the suture used. If Blue ORTHOCORD sutures were used, providers should review the clinical outcome in light of the corrected strength retention data.
The recalled product
- 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.
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Category
- Medical Device — Sutures
- Hazard
- Affected units
- 65,062
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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