FDA Enforcement
Class II
Terminated
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: Z-0458-2014
·
Reported December 18, 2013
Enforcement
- Recall Number
- Z-0458-2014
- Event ID
- 66627
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Ethicon, Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- December 18, 2013
- Initiation Date
- September 25, 2013
- Classification Date
- December 6, 2013
- Termination Date
- May 6, 2016
- Address
- US Highway 22 West, Somerville, NJ, 08876, United States
Description
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.
Code Info
K113004 D183642 All product codes beginning with SXPP1A.
Distribution
Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
Quantity
37,164 eaches