Recall Z-0409-2018— Smith & Nephew, Inc.
Class II · Terminated
Class II FDA medical device recall by Smith & Nephew, Inc., initiated 2017-12-13, terminated 2020-10-05. It names one FDA 510(k) clearance: K142520. 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.. 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..
- Recalling firm
- Smith & Nephew, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-12-13
- Terminated
- 2020-10-05
- Firm location
- Memphis, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.