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Terminated

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.

FDA Recall Z-0409-2018 · Posted 2018-01-08

Recalling FirmSmith & Nephew, Inc.
Recall StatusTerminated
Product CodeOSN
Date Initiated2017-12-13
Date Terminated2020-10-05
Product QuantityN/A

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.

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.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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