Recall – Cl II Hoffmann LRF Hexapod Software

Company: Stryker GmbH.
Date of Enforcement Report 10/3/2018
Class II:

PRODUCT
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

Recall Number: Z-3240-2018

REASON
When creating a correction plan with the Correct Axial First button selected and the No. of corrections per day set to more than 1 (e.g., 2, 3, or 4), the Hexapod Software computes an erroneously accelerated correction plan for the axial portion of the plan.

RECALLING FIRM/MANUFACTURER
Stryker GmbH, Selzach, Switzerland on 7/26/2018 Voluntary: Firm Initiated

VOLUME OF PRODUCT IN COMMERCE
233

DISTRIBUTION
Nationwide

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About the author

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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