Navitrack System - OS Knee Universal recalled over injury risk

Recall date

October 6, 2011

Source

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

Official notice title

Orthosoft, Inc. dba Zimmer CAS recalls Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in…

Recall number

Z-1881-2017

FDA classification

Class II

Brand / firm

Orthosoft, Inc. dba Zimmer CAS

Sold / distributed

Worldwide Distribution - US including AZ CA CO FL GA IL IN KS MD MI MN MS OH OR PA SC SD TX VA WA and WI Internationally to Canada, Australia Austria Colombia Denmark France Germany Korea New Zealand Russia South Africa and Thailand

Why it was recalled

Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal software ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.

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

What was recalled

Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument CAS Software application intended to assist in the placement of total knee replacement components