Company: Smith & Nephew
Date of Enforcement Report 12/22/2010
Class ll:
PRODUCT
Smith & Nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative image-guided localization system. It is a computer-assisted orthopedic surgery tool to aid the surgeon with drill positioning for screws during intramedullary nail implantation. Recall # Z-0411-2011
REASON
Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails.
RECALLING FIRM/MANUFACTURER
Smith & Nephew Inc., Memphis, TN, by letter dated October 4, 2010. Firm initiated recall is ongoing. .
VOLUME OF PRODUCT IN COMMERCE
445 units
DISTRIBUTION
Nationwide and internationally
