Smith & Nephew, Inc.: Medical Device Recall in 2018 - (Recall #: Z-0409-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: December 13, 2017

Date Posted: January 31, 2018

Recall Number: Z-0409-2018

Event ID: 78840

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.

Status: Terminated

Product Quantity: N/A

Code Information:

Version 5.2.5 and 5.2.6

Distribution Pattern:

Worldwide

Voluntary or Mandated:

Voluntary: Firm initiated