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ORTHOCORD ONE VIOLET AND ONE BLUE BRAIDED COMPOSITE SUTURE… recallZ-1173-2013 · DePuy Mitek, Inc., a Johnson & Johnson Co. · initiated Mar 22, 2013

Class II Terminated All recalls posted in April 2013

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from DePuy Mitek, Inc., a Johnson & Johnson Co. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six

FDA root cause category: Labeling Change Control

What the company is doing

On March 22, 2013, firm notified consignees of recall via letter. Consignees were informed of the following: The IFU provided with the free strand ORTHOCORD sutures currently indicates that approximately 100% suture strength remains at six weeks after implantation. While this statement is true for Violet ORTHOCORD sutures, it is an inaccurate statement for Blue ORTHOCORD free strand sutures. Based on in-vivo strength retention study, a Blue ORTHOCORD sutures maintain approximately 80% of strength at six weeks after implantation. As Blue and Violet ORTHOCORD free strand sutures share the same IFU, IFU-108147 will be revised. Consignees were requested to confirm the receipt of the letter by March 29, 2013.

Recall details

Recall number
Z-1173-2013
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 22, 2013
Posted by the FDA
Apr 25, 2013
Recalling firm
DePuy Mitek, Inc., a Johnson & Johnson Co.
Quantity
84174
Product code
NEW
FDA submissions
K043298
Distribution
Nationwide Distribution.

Product description

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.

Code information (models, lots, serial numbers)

ALL from Jan 1 2010 - Corrected IFU implementation date

Other devices under the same FDA submission

3 devices cleared under K043298 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 64706).

Sources and updates

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