Recall Z-2076-2017 ยท HAW Neurological Stereotaxic Instrument
Orthosoft, Inc. dba Zimmer CAS
Navitrack System - OS Knee Universal, Stereotaxic instrument
| Date | May 12, 2017 (initiated Oct 28, 2008) |
| Status | Terminated |
| Reason | 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 . |
| Root cause | Software design |
| Action | This is a retrospective report of a correction taken on 28 October, 2008. The software issues mentioned above were corrected in subsequent software updates. There were 153 units of the affected software distributed. There were 147 of the 153 units confirmed to have installed the updated software per the correction notice for a total percentage of 96%. Recall Notices were sent to customers on 10/28/2008. |
| Quantity | 153 |
| Distribution | 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 |
| 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 |