Recall Z-2075-2017 ยท HAW Neurological Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument
| Date | May 12, 2017 (initiated Jun 20, 2008) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| Action | This is a retrospective report of a correction taken on 20 June 2008. The two software issues were corrected in the new software version 2.2.1.3. There were 164 copies of the affected software, 5 of which were only temporary licenses. There were 152 of the 159 software copies that had a full license that were confirmed to have installed the updated instructions per the correction notice for a total percentage of 96%. All sales representatives were made aware of the software issues by written notice. Both software issues were corrected in a new revision of the software with no remaining effect. |
| Quantity | 152 |
| Distribution | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K060336 | NAVITRACK SYSTEM-OS KNEE UNIVERSAL, MODEL PRO-05002 Orthosoft, Inc., Apr 28, 2006 |