Recall Z-0458-2014 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
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.
| Date | Dec 6, 2013 (initiated Sep 25, 2013) |
| Status | Terminated |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K113004 | PDS(TM) BARBED SUTURES ETHICON, Inc., Dec 20, 2011 |