Z-0409-2018Class II

Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile...

Name: Z-0409-2018 Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile...
Creator: Smith & Nephew, Inc.
Published: 2017-12-13
License: https://open.fda.gov/license/

Smith & Nephew, Inc. / initiated 2017-12-13 / Terminated / root cause: software

FDA source

Smith & Nephew, Inc. began a recall of Smith & Nephew Taylor Spatial Frame Website software, Catalog Number 71070401. A web-based and mobile application software component of a multilateral external... on 2017-12-13. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as software.

Recall record

Recall number: Z-0409-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-13
Posted: 2018-01-08
Terminated: 2020-10-05
Recalling firm: Smith & Nephew, Inc.
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.
Product code: OSN Software For Diagnosis/Treatment
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.
Root cause tag: software
FDA 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 in commerce: N/A
Distribution: Worldwide
Product codes and lots: Version 5.2.5 and 5.2.6

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0409-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0409-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-31	2018-01-24

Product code OSN

K142520Class IISmith & Nephew, Inc. Spatialframe.com V5.0 Web-based softwareSmith & Nephew, Inc. / cleared 2014-11-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)