FDA Device recall Z-0458-2014
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969
- FDA Device
- Class II
- terminated
- Published 2013-12-18
On 2013-12-18 the FDA classified a Class II recall of Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969 by Ethicon, citing ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0458-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-09-25 |
| Published | 2013-12-18 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ethicon |
| Distribution | US |
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.
Reason
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
Identifiers
| code_info | K113004 D183642 All product codes beginning with SXPP1A. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0458-2014%22
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