FDA Medical Device Recalls (openFDA)
Smith & Nephew, Inc.: 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.
- Recall number
- Z-0409-2018
- 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.
- Status
- Terminated
- Initiated
- 2017-12-13
- Posted
- 2018-01-08
- Terminated
- 2020-10-05
- Reason
- 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
- 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
- N/A
- Distribution
- Worldwide
- Lot, serial or model codes
- Version 5.2.5 and 5.2.6
- 510(k) numbers
- ["K142520"]
- PMA numbers
- not on file
- Product code
- OSN
- Firm FEI
- 1020279
- Firm city
- Memphis
- Firm state
- TN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28