Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1176-2013·Announced 2013-05-01

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.

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 involves a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error regarding strength retention, which is a moderate risk.

Plain-English summary

DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling ORTHOCORD One Violet and One Blue Braided Composite Sutures with OS-6 Reverse Cutting Needles (Product Code: 223116). The recall involves 46,501 units distributed nationwide.

The recall was initiated because the Instructions for Use (IFU) provided with the free strand ORTHOCORD sutures incorrectly indicate 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. In-vivo strength retention studies indicate that Blue ORTHOCORD sutures maintain approximately 80% of their strength at six weeks.

The affected products are intended for use in general soft tissue approximation and/or ligation, including orthopedic procedures. The recall covers all units from January 1, 2010, through the corrected IFU implementation date. Healthcare providers and facilities should stop using the affected Blue ORTHOCORD sutures and contact the manufacturer for instructions on how to return the product.

The recalled product

Product: ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.
Manufacturer: DePuy Mitek, Inc., a Johnson & Johnson Co.
Category: Medical Device — Surgical Sutures
Hazard: mis-labeling
Affected units: 46,501

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.

See all 5 products in this recall →

Same manufacturer · DePuy Mitek, Inc., a Johnson & Johnson Co.

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Same hazard · mis labeling