Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device Ethicon LLC Guaynabo, Puerto Rico 00969. Intended fo
FDA device recall Z-0458-2014 · posted 2013-12-06 · Terminated
Recall details
- Recalling firm
- Ethicon, Inc.
- 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.
- Action taken
- Ethicon Inc. sent recall notifications/business reply forms on 9/25/2013 via UPS next day certified mail.
- Root cause
- Unknown/Undetermined by firm
- Status
- Terminated
- Product code
- NEW
- Quantity affected
- 37,164 eaches
- Distribution
- Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
- Date initiated
- 2013-09-25
- Date posted
- 2013-12-06
- Date terminated
- 2016-05-06
- Location
- Somerville, NJ
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PDS(TM) BARBED SUTURES (K113004) | ETHICON, Inc. | 2011-12-20 |