FDA-Device2014-07-23Class II

SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 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
259 units
Manufactured in
150 Minuteman Drive, N/A, Andover, MA, United States
Products
SUTUREFIX Ultra Anchor XL with one (#2) Ultrabraid Blue Product Code: 72203841 Fastener, fixation, nondegradable, soft tissue

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2045-2014

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