Home / Recalls / Medical Devices
Smith & Nephew, Inc. Endoscopy Division recalls SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Recalled July 23, 2014 · FDA recall Z-2047-2014 · Smith & Nephew, Inc. Endoscopy Division
Hazard
Sterility of device is compromised due to breach in sterile barrier · FDA Class II
Units
907 units
Sold at
Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.
Description
Sterility of device is compromised due to breach in sterile barrier
Product
SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue
Manufacturer(s)
Smith & Nephew, Inc. Endoscopy Division
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →