Drug recall
Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile…
FDA recall event 78840 · Class II · Smith & Nephew, Inc.
Key facts
| Event ID | 78840 |
|---|---|
| Recall numbers | Z-0409-2018 |
| Recalling firm | Smith & Nephew, Inc. |
| Product type | Devices |
| Products | Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external fixation system that is intended for… |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | In rare circumstances, when surgeons use the software to plan the strut adjustment, an inverted image of the frame is generated by the software. The frame will appear inverted in the preview images on… |
| Initiation date | Dec 13, 2017 |
| Report date | Jan 31, 2018 |
| Termination date | Oct 5, 2020 |
| City | Memphis |
| State | TN |
| Country | United States |
| FEI number | 1020279 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: