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U.S. Department of Health and Human Services

Class 2 Device Recall Taylor Spatial Frame Website software

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  Class 2 Device Recall Taylor Spatial Frame Website software see related information
Date Initiated by Firm December 13, 2017
Date Posted January 08, 2018
Recall Status1 Terminated 3 on October 05, 2020
Recall Number Z-0409-2018
Recall Event ID 78840
510(K)Number K142520  
Product Classification Software for diagnosis/treatment - Product Code OSN
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.
Code Information Version 5.2.5 and 5.2.6
Recalling Firm/
Manufacturer		 Smith & Nephew, Inc.
1450 E Brooks Rd
Memphis TN 38116-1804
For Additional Information Contact Dave Snyder
978-749-1440
Manufacturer 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 2		 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 in Commerce N/A
Distribution Worldwide
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = OSN and Original Applicant = Smith & Nephew, Inc
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