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

Recall date

July 26, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-3240-2018

FDA classification

Class II

Brand / firm

Stryker GmbH

Sold / distributed

Nationwide

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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