FDA-Device2018-10-03Class II

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

Stryker GmbH
Hazard

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.

Sold states
Nationwide
Affected count
233
Manufactured in
Bohnackerweg 1, Selzach, Switzerland
Products
Hoffmann LRF Hexapod Software Catalog #: 983031 Software Version #: HLRF 1.0-2/002, HLRF 1.1-2/002

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3240-2018

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