Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application softwa
FDA device recall Z-0409-2018 · posted 2018-01-08 · Terminated
Recall details
- Recalling firm
- Smith & Nephew, Inc.
- 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 the Strut Settings tab.
- Action taken
- The firm initiated their recall by email on 12/13/2017. Users are asked if they notice an inverted frame in the software to repeat the process for the same case and notify a Smith & Nephew representative. In addition, they are asked to double check plannings for strut adjustments and compare with the images printed as described above.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- OSN
- Quantity affected
- N/A
- Distribution
- Worldwide
- Date initiated
- 2017-12-13
- Date posted
- 2018-01-08
- Date terminated
- 2020-10-05
- Location
- Memphis, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software (K142520) | Smith & Nephew, Inc. | 2014-11-20 |