Orthosoft, Inc. dba Zimmer CAS recalls Navitrack System - OS Knee Universal, Stereotaxic instrument

Recall date

October 28, 2008

Source

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

Recall number

Z-2076-2017

FDA classification

Class II

Brand / firm

Orthosoft, Inc. dba Zimmer CAS

Sold / distributed

Domestic: CA, FL, GA, IL, IN, KS, NC, NY, OH, OR, PA, RI, TN, TX, VA, WA Foreign: Canada, Australia Austria Brazil China Czech Republic France Germany Israel Italy Lebanon Luxembourg Netherlands New Zealand Spain Sweden Switzerland United Kingdom

Why it was recalled

Zimmer CAS voluntarily conducted a retrospective recall of the Navitrack System OS Knee Universal software versions 2.2.0.82, 2.2.1.3, 2.1.6.0.2, D.54 and A.42 due to software issues resulting in erros and discrepancies .

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, Stereotaxic instrument