Navitrack System - OS Knee Universal, Stereotaxic instrument
This recall has been terminated (originally issued May 12, 2017).
- Company
- Orthosoft, Inc. Dba Zimmer Cas
- Recall Initiated
- October 28, 2008
- Posted
- May 12, 2017
- Terminated
- May 15, 2017
- Recall Number
- Z-2076-2017
- Quantity
- 153
- Official Source
- View on FDA website ↗
Reason for Recall
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 .
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
Lot / Code Info
Part Number, Lot Number/Serial Number ORTHOsoft-UniTkr- 2.2.0.82, 2.2.1.3 ORTHOsoft-UniTkr- 2.1.6.0.2 OsUniTkr (previous naming convention for ORTHOsoft-UniTkr)- D.54, A.42
Root Cause
Software design
Action Taken
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.