Device 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.
Z-0458-2014
Product summary
- Firm
- Ethicon, Inc.
- Event
- Event 66627
- Status
- Terminated
- Classification
- Class II
- Quantity
- 37,164 eaches
- Official record key
device-enforcement:Z-0458-2014
Official wording
Reason: Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
Code information: K113004 D183642 All product codes beginning with SXPP1A.
Distribution pattern: Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
Derived failure modes
-
Unknown
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.