FDA-Device2013-12-18Class II
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.
Ethicon, Inc.
Hazard
Ethicon Stratafix Symmetric PDS Plus Knotless Tissue Control Device has a small number of tab failures and fascial dehiscences in lower abdominal incisions.
Sold states
Worldwide Distribution-USA (nationwide) and countries of: Caribbean, Chile, Singapore and Malaysia.
Affected count
37,164 eaches
Manufactured in
US Highway 22 West, Somerville, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0458-2014Don't want to check this manually?
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