Recall Z-0409-2018
Smith & Nephew, Inc. · initiated December 13, 2017
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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 fracture fixation, fixation of long bones and for joint fusions and limb lengthening or deformity corrections which involve cutting of the bone.
Codes / lots: Version 5.2.5 and 5.2.6
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.
FDA-determined cause: Under Investigation by firm
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.
Details
- Recall number
- Z-0409-2018
- Initiated
- December 13, 2017
- Posted by FDA
- January 8, 2018
- Terminated
- October 5, 2020
- Product code
- OSN – Software For Diagnosis/Treatment
- Quantity
- N/A
- Distribution
- Worldwide
- Recalling firm
- Smith & Nephew, Inc., Memphis, TN