Ethicon, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0458-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: September 25, 2013

Date Posted: December 18, 2013

Recall Number: Z-0458-2014

Event ID: 66627

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.

Status: Terminated

Product Quantity: 37,164 eaches

Code Information:

K113004 D183642 All product codes beginning with SXPP1A.

Distribution Pattern:

Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.

Voluntary or Mandated:

Voluntary: Firm initiated