Z-0411-2011

smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1...

Name: Z-0411-2011 smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1...
Creator: Smith & Nephew Inc
Published: 2010-10-15
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2010-10-15 / Terminated / root cause: software

FDA source

Smith & Nephew Inc began a recall of smith & nephew TRIGEN SURESHOT Distal Targeting System, Trauma Interface, V2.0.2, Trauma Launcher V1.01.1 Product is intended to be an intraoperative... on 2010-10-15. The reason FDA records is "Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0411-2011
Status: Terminated
Initiated: 2010-10-15
Posted: 2010-11-18
Terminated: 2011-02-17
Recalling firm: Smith & Nephew, Inc.
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.
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails.
Root cause tag: software
FDA root cause: Other
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.
Product codes and lots: All serial numbers prior to and including ACA5

Product code OLO

K100107Class IISmith & Nephew Sureshot Distal Targeting System V2.0Smith & Nephew, Inc. / cleared 2010-02-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)