Z-0409-2018 Class II Terminated
FDA device recall Z-0409-2018 was initiated by Smith & Nephew, Inc. on December 13, 2017 and is designated Class II. 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 image… The recall status is terminated (terminated October 5, 2020). Affected quantity: N/A.
Recall Details
- Product Type
- Devices
- Report Date
- January 31, 2018
- Initiation Date
- December 13, 2017
- Termination Date
- October 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
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.
Distribution Pattern
Worldwide
Code Information
Version 5.2.5 and 5.2.6