Recall Z-0411-2011 ยท OLO Orthopedic Stereotaxic Instrument
Smith & Nephew Inc
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.
| Date | Nov 18, 2010 (initiated Oct 15, 2010) |
| Status | Terminated |
| Reason | Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails. |
| 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 | 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, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100107 | SMITH & NEPHEW SURESHOT DISTAL TARGETING SYSTEM V2.0 Smith & Nephew, Inc., Feb 23, 2010 |