DePuy Mitek Recalls Blue Orthocord Sutures Due to Inaccurate Strength Labeling
DePuy Mitek is recalling Blue Orthocord sutures because the instructions for use incorrectly state they retain 100% strength at six weeks, when they actually retain approximately 80%.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically indicates a situation where use of the product may cause temporary or medically reversible adverse health consequences. The hazard is a labeling error regarding strength retention rather than a direct contamination or structural failure, fitting the Moderate severity criteria for minor labeling errors or low-risk issues.
Plain-English summary
DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling 84,174 units of ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number 223113. The product is distributed nationwide and is intended for general soft tissue approximation and ligation, including orthopedic procedures.
The recall is due to an inaccuracy in the Instructions for Use (IFU) provided with the free strand ORTHOCORD sutures. The IFU currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is accurate for Violet ORTHOCORD sutures, it is inaccurate for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention studies, Blue ORTHOCORD sutures maintain approximately 80% of their strength at six weeks.
The affected units are all lots manufactured 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 further instructions regarding the return or replacement of the product.
The recalled product
- 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.
- Manufacturer
- DePuy Mitek, Inc., a Johnson & Johnson Co.
- Affected units
- 84,174
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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