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.
Reported: December 18, 2013 Initiated: September 25, 2013 #Z-0458-2014
Product 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 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.
Details
- Recalling Firm
- Ethicon, Inc.
- Units Affected
- 37,164 eaches
- Distribution
- Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
- Location
- Somerville, NJ
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Ethicon, Inc.. Units affected: 37,164 eaches.
Why was this product recalled? ▼
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on December 18, 2013. Severity: Moderate. Recall number: Z-0458-2014.
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