Orthosoft, Inc. dba Zimmer CAS recalls Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
- Recall date
- June 20, 2008
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2075-2017
- FDA classification
- Class III
- Brand / firm
- Orthosoft, Inc. dba Zimmer CAS
- Sold / distributed
- Domestic: CA, FL, GA, IL, IN, KS, MD, MN, MS, NC, NJ, NY, OR, PA, RI, SD, TN, TX, WA, WI Foreign: Germany, Spain, Czech Republic, Netherlands, Switzerland, New Zealand, Morocco, Brazil, Australia, Austria, France, Italy, Singapore, United Kingdom
Why it was recalled
ZIMMER CAS voluntarily conducted a retrospective recall of the Navitrack System - OS Knee Universal, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
Class III means the product violates regulations but is not likely to cause harm.
What was recalled
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
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