Device product
Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
Z-2075-2017
Product summary
- Event
- Event 75612
- Status
- Terminated
- Classification
- Class III
- Quantity
- 152
- Official record key
device-enforcement:Z-2075-2017
Official wording
Reason: 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.
Code information: Product Name: Orthosoft Universal TKR (software application) Product Number: ORTHOsoft-UniTkr-2 Affected Lot #: Software release version ORTHOsoft-UniTkr-2.2.0.82
Distribution pattern: 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
Derived failure modes
-
Device software or design
software anomalies