FDA-Device2014-07-23Class II

SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue

Smith & Nephew, Inc. Endoscopy Division
Hazard

Sterility of device is compromised due to breach in sterile barrier

Sold states
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
Affected count
1086 untis
Manufactured in
150 Minuteman Drive, N/A, Andover, MA, United States
Products
SUTUREFIX Ultra S with 1 #2 Ultrabraid Suture (blue/white) Product Code: 72203853 Fastener, fixation, nondegradable, soft tissue

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2048-2014

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