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.
This recall has been terminated (originally issued January 8, 2018).
- Company
- Smith & Nephew Inc
- Recall Initiated
- December 13, 2017
- Posted
- January 8, 2018
- Terminated
- October 5, 2020
- Recall Number
- Z-0409-2018
- Firm Location
- Memphis, TN
- Official Source
- View on FDA website ↗
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.
Distribution
Worldwide
Lot / Code Info
Version 5.2.5 and 5.2.6
Root 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.
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