Recall Z-0409-2018 ยท OSN Software For Diagnosis/Treatment
Smith & Nephew, Inc.
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.
| Date | Jan 8, 2018 (initiated Dec 13, 2017) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Under Investigation by firm |
| Action | 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. |
| Quantity | N/A |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K142520 | Smith & Nephew, Inc. Spatialframe.com V5.0 Web-based software Smith & Nephew, Inc., Nov 20, 2014 |