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U.S. Department of Health and Human Services

Class 3 Device Recall Navitrack System OS Knee Universal

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  Class 3 Device Recall Navitrack System OS Knee Universal see related information
Date Initiated by Firm June 20, 2008
Date Posted May 12, 2017
Recall Status1 Terminated 3 on May 15, 2017
Recall Number Z-2075-2017
Recall Event ID 75612
510(K)Number K060336  
Product Classification Neurological stereotaxic Instrument - Product Code HAW
Product Navitrack¿ System - OS Knee Universal, Orthopedic Stereotaxic Instrument
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
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, due to software anomalies which were corrected with a new revision in version 2.2.1.3.
FDA Determined
Cause 2		 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. There have been no complaints since the correction was implemented. Recall notices were e-mailed to customers dated 06/20/2008.
Quantity in Commerce 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
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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