Recalls / —
—#160710
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.
- FDA product code
- OSN — Software For Diagnosis/Treatment
- Device class
- Class 2
- Medical specialty
- Orthopedic
- 510(k) numbers
- K142520
- Affected lot / code info
- Version 5.2.5 and 5.2.6
Why it was recalled
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 (FDA determination)
Under Investigation by firm
Action the firm took
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.
Recalling firm
- Firm
- Smith & Nephew, Inc.
- Address
- 1450 E Brooks Rd, Memphis, Tennessee 38116-1804
Distribution
- Distribution pattern
- Worldwide
Timeline
- Recall initiated
- 2017-12-13
- Posted by FDA
- 2018-01-08
- Terminated
- 2020-10-05
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #160710. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.