CLASS II Device recall · Reported 1 May 2013 · FDA Enforcement Report

Orthocord Blue Braided Composite Suture 2 (5 Metric) recalled

DePuy Mitek, Inc., a Johnson & Johnson is recalling Orthocord Blue Braided Composite Suture 2 (5 Metric), distributed nationwide in the US. The recall was initiated on 22 Mar 2013 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesALL from Jan 1 2010 - Corrected IFU implementation date

Quantity recalled65062

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1172-2013
FDA event ID: 64706
Recalling firm: DePuy Mitek, Inc., a Johnson & Johnson, Raynham, MA
Classification: Class II
Status: Terminated
Recall initiated: 22 Mar 2013
FDA classified: 25 Apr 2013
Reported: 1 May 2013
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Labeling Errors
Device type: Hip & Knee Implants

Timeline

22 Mar 2013	Recall initiated by company
25 Apr 2013	Classified by FDA	+34 days
1 May 2013	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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

Product as listed by the FDA

ORTHOCORD BLUE BRAIDED COMPOSITE SUTURE 2 (5 METRIC), Catalog Number: 223111. For use in general soft tissue approximation, and/or ligation, including orthopedic procedures.

Where it was distributed

Nationwide Distribution.

Nationwide

Questions about this recall

Why was it recalled?

Which lots are affected?

ALL from Jan 1 2010 - Corrected IFU implementation date

Where was it sold?

Nationwide Distribution.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 64706

This product is part of a recall event; the main page for the event is Orthocord One Violet and One Blue Braided Composite Suture recalled.

Reported	Class	Recall	Company	Reason	Where
1 May 2013	CLASS II	Orthocord One Violet and One Blue Braided Composite Suture recalled	DePuy Mitek, Inc., a Johnson & Johnson	Labeling Errors	Nationwide
1 May 2013	CLASS II	Orthocord One Violet and One Blue Braided Composite Suture recalled	DePuy Mitek, Inc., a Johnson & Johnson	Labeling Errors	Nationwide
1 May 2013	CLASS II	Orthocord One Violet And One Blue Braided Composite Suture recalled	DePuy Mitek, Inc., a Johnson & Johnson	Labeling Errors	Nationwide
1 May 2013	CLASS II	Orthocord One Violet and One Blue Braided Composite Suture recalled	DePuy Mitek, Inc., a Johnson & Johnson	Labeling Errors	Nationwide

More recalls from DePuy Mitek, Inc., a Johnson & Johnson

All 51

Reported	Class	Recall	Company	Reason	Where
19 Mar 2025Device	CLASS II	COR Disposable Kit w/ Perpendicularity recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
19 Mar 2025Device	CLASS II	COR Disposable Kit Cartilage Transplant System recalled	DePuy Mitek, Inc., a Johnson & Johnson	Other	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Rapid w/ Pan-Indicated for use recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Plus w/ Ethibond-Iindicated recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide
14 Jun 2023Device	CLASS II	DePuy Mitek Bioknotless Rapid W/ OC-Indicated for use recalled	DePuy Mitek, Inc., a Johnson & Johnson	Device Malfunction	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide