smith & nephew TRIGEN SURESHOT Distal Targeting System… recallZ-0411-2011 · Smith & Nephew Inc · initiated Oct 15, 2010
Terminated All recalls posted in November 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smith & Nephew Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails.
FDA root cause category: Other
What the company is doing
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.
Recall details
- Recall number
- Z-0411-2011
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 15, 2010
- Posted by the FDA
- Nov 18, 2010
- Recalling firm
- Smith & Nephew Inc
- Quantity
- 445 units
- Product code
- OLO
- FDA submissions
- K100107
- 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 description
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 (models, lots, serial numbers)
All serial numbers prior to and including ACA5
Other devices under the same FDA submission
6 devices cleared under K100107 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- TRIGEN 71692815Smith & Nephew, Inc. · Orthopedic stereotaxic instrument8 reports
- TRIGEN 71692809Smith & Nephew, Inc. · Orthopedic stereotaxic instrument8 reports
- TRIGEN 71692803Smith & Nephew, Inc. · Orthopedic stereotaxic instrument3 reports
- TRIGEN 71692810Smith & Nephew, Inc. · Orthopedic stereotaxic instrument2 reports
- TRIGEN 71692806Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 report
- TRIGEN 71692811Smith & Nephew, Inc. · Orthopedic stereotaxic instrument1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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