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U.S. Department of Health and Human Services

Class 2 Device Recall Navitrack System OS Knee Universal, Stereotaxic instrument

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  Class 2 Device Recall Navitrack System OS Knee Universal, Stereotaxic instrument see related information
Date Initiated by Firm October 28, 2008
Date Posted May 12, 2017
Recall Status1 Terminated 3 on May 15, 2017
Recall Number Z-2076-2017
Recall Event ID 75613
510(K)Number K060336  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product Navitrack System - OS Knee Universal, Stereotaxic instrument
Code Information 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
Recalling Firm/
Manufacturer		 Orthosoft, Inc. dba Zimmer CAS
75 Queen St #3300
Montreal Canada
For Additional Information Contact Kevin Escapule
574-372-4487
Manufacturer 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 .
FDA Determined
Cause 2		 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 in Commerce 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
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = HAW and Original Applicant = ORTHOSOFT, INC.
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