Recall
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…
Smith & Nephew Inc · 15 Oct 2010
- Status
- Recall terminated
- Why, in the FDA's words
- “Targeting software has been found to provide erroneous targeting when used with the 13 mm TAN/FAN Left nails.”
- Recall began
- 15 Oct 2010
- Company
- Smith & Nephew Inc
- Device type
- Orthopedic stereotaxic instruments (knee, hip and spine robots) (OLO)
- Concerns
- K100107
What it means
A recall is the FDA's record that a company is correcting or removing a device because of a problem. Many are fixed with a software update or new instructions; the record does not say whether anyone was hurt. See our plain guide to FDA terms.
The record
The FDA publishes this record in its public device database. The summary documents the company filed, when available, are linked from the FDA's page.