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U.S. Department of Health and Human Services

Class 2 Device Recall TRIGEN SURESHOT Distal Targeting System

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 Class 2 Recall
TRIGEN SURESHOT Distal Targeting System
see related information
Date Posted November 18, 2010
Recall Status1 Terminated on February 17, 2011
Recall Number Z-0411-2011
Recall Event ID 57047
Premarket Notification
510(K) Number
K100107 
Product Classification Orthopedic Stereotaxic Instrument - Product Code OLO
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.
Code Information All serial numbers prior to and including ACA5
Recalling Firm/
Manufacturer
Smith & Nephew Inc
1450 E. Brooks Rd
Memphis, Tennessee 38116
For Additional Information Contact Victor Rocha
901-399-6771
Manufacturer Reason
for Recall
Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails.
FDA Determined
Cause 2
OTHER/UNDETERMINED: Pending
Action Smith & Nephew Inc. sent an URGENT MEDICAL DEVICE CORRECTION letter by FedEx on October 15, 2010, to all customers. The letter was dated October 4, 2010, and identified the product, the problem, and the action to be taken by the customers. Customers were instructed to perform a software upgrade and complete the form provided and return by fax to (901) 566-7835. For questions regarding this recall call (901) 399-5441.
Quantity in Commerce 445 units
Distribution Worldwide Distribution - USA including AL, AR, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MA, MD, MI, MN, MO, MS, NC, NJ, NM, OH, PA, TN, TX, AND WA and the countries of Australia, Belgium, Canada, China, Denmark, Finland, France, Germany, Italy, Japan, Netherlands, Norway, South Africa, Spain, Sweden, Switzerland, Turkey, and the UK.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = OLO and Original Applicant = SMITH & NEPHEW, INC.
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