Skip to content
Recall Observatory FDA recall evidence

Device product

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

Z-3240-2018

July 26, 2018

Class II

Product summary

Firm
Stryker GmbH
Event
Event 80863
Status
Terminated
Classification
Class II
Quantity
233
Official record key
device-enforcement:Z-3240-2018

Official wording

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.

Code information: Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.