FDAOctober 6, 2011device

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

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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.

What to do

FDA enforcement status: Terminated

Brands named

orthosoft inc dba zimmer casorthosoftorthosoft inc

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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