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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 Device Recall TRIGEN SURESHOT Distal Targeting Systemsee related information
Date Initiated by FirmOctober 15, 2010
Date PostedNovember 18, 2010
Recall Status1 Terminated 3 on February 17, 2011
Recall NumberZ-0411-2011
Recall Event ID 57047
510(K)NumberK100107 
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Productsmith & 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 TN 38116
For Additional Information ContactVictor 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
ActionSmith & 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 Commerce445 units
DistributionWorldwide 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 CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = OLO
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