Agency classClass IIOur severity:Moderate FDA (Devices)·Z-1175-2013·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: This is an FDA Class II recall involving a labeling error regarding suture strength retention. No injuries or illnesses are reported, and the hazard is theoretical, fitting the criteria for a moderate severity score.

Plain-English summary

DePuy Mitek, Inc., a Johnson & Johnson Co., is recalling ORTHOCORD One Violet and One Blue Braided Composite Suture with MO-6 Taper Needles, Product Code 223115. The recall involves 46,732 units distributed nationwide.

The recall is due to an inaccuracy in the Instructions for Use (IFU) provided with the free strand ORTHOCORD sutures. The IFU states 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, which maintain approximately 80% of strength at six weeks based on in-vivo strength retention studies.

The recall covers all units from January 1, 2010, to 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-6 Taper Needles, Product Code: 223115. 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: 46,732

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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