22
Dec
2010

Cl ll TRIGEN SURESHOT Distal Targeting System

0

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

About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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