Z-1176-2013Class II

ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles

Name: Z-1176-2013 ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles
Creator: DePuy Mitek, Inc., a Johnson & Johnson Co.
Published: 2013-03-22
License: https://open.fda.gov/license/

DePuy Mitek, Inc. / initiated 2013-03-22 / Terminated / root cause: labeling and UDI

FDA source

DePuy Mitek, Inc., a Johnson & Johnson Co. began a recall of ORTHOCORD One Violet and One Blue Braided Composite Suture with OS-6 Reverse Cutting Needles, Product Code: 223116. For use in general soft tissue... on 2013-03-22. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1176-2013
Classification: Class II
Status: Terminated
Initiated: 2013-03-22
Posted: 2013-04-25
Terminated: 2014-02-24
Recalling firm: DePuy Mitek, Inc.
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.
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: 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
Root cause tag: labeling and UDI
FDA root cause: Labeling Change Control
Action: 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.
Quantity in commerce: 46501
Distribution: Nationwide Distribution.
Product codes and lots: ALL from Jan 1 2010 - Corrected IFU implementation date

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1176-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1172-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-25
Z-1173-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-25
Z-1174-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-25
Z-1175-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-25
Z-1176-2013	Class II	Terminated	Voluntary: Firm initiated	2013-05-01	2013-04-25

Product code NEW

K043298Class IIBlue Orthocord SutureDepuy Mitek / cleared 2004-12-10

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)