Z-0458-2014Class II

Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969...

Name: Z-0458-2014 Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969...
Creator: Ethicon, Inc.
Published: 2013-09-25
License: https://open.fda.gov/license/

Ethicon, Inc / initiated 2013-09-25 / Terminated

FDA source

Ethicon, Inc. began a recall of Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation... on 2013-09-25. FDA classified it as Class II and gives the reason as "Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0458-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-25
Posted: 2013-12-06
Terminated: 2016-05-06
Recalling firm: Ethicon, Inc
Product: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended for general soft tissue approximation where use of an absorbable suture is appropriate.
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
FDA root cause: Unknown/Undetermined by firm
Action: Ethicon Inc. sent recall notifications/business reply forms on 9/25/2013 via UPS next day certified mail.
Quantity in commerce: 37,164 eaches
Distribution: Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
Product codes and lots: K113004 D183642 All product codes beginning with SXPP1A.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0458-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0458-2014	Class II	Terminated	Voluntary: Firm initiated	2013-12-18	2013-12-06

Product code NEW

K113004Class IIPds(tm) Barbed SuturesETHICON, Inc. / cleared 2011-12-20

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)