FDA Medical Device Recalls (openFDA)
Ethicon, Inc.: 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.
- Recall number
- Z-0458-2014
- 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.
- Status
- Terminated
- Initiated
- 2013-09-25
- Posted
- 2013-12-06
- Terminated
- 2016-05-06
- Reason
- Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
- 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
- 37,164 eaches
- Distribution
- Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
- Lot, serial or model codes
- K113004 D183642 All product codes beginning with SXPP1A.
- 510(k) numbers
- ["K113004"]
- PMA numbers
- not on file
- Product code
- NEW
- Firm FEI
- 2210968
- Firm city
- Somerville
- Firm state
- NJ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28