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U.S. Department of Health and Human Services

Class 2 Device Recall Navitrack System OS Knee Universal

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  Class 2 Device Recall Navitrack System OS Knee Universal see related information
Date Initiated by Firm October 06, 2011
Date Posted April 26, 2017
Recall Status1 Terminated 3 on May 08, 2017
Recall Number Z-1881-2017
Recall Event ID 75614
510(K)Number K110054  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Navitrack System - OS Knee Universal, Orthopedic Stereotaxic Instrument
CAS Software application intended to assist in the placement of total knee replacement components
Code Information Part Name: OS Knee Universal Part Number: ORTHOsoft-UniTkr-2 Affected Lot: ORTHOsoft-UniTkr-2.3.2.6
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 ORTHOsoft-UniTkr-2.3.2.6, due to a calibration sequence crash.
FDA Determined
Cause 2		 Software design
Action Zimmer sent a Medical Device Field Notification letter dated December 6, 2011, to all affected customers. This is a retrospective report of a correction taken on 6 December 2011. The software issues were fixed in the new software version 2.3.3.0. Recall notices were distributed on December 6, 2011. Telephone: 18663367846 (US & Canada) or 5143958883 (International), Email: cassupport@zimmercas.com Customers with questions should call 1-866-336-7846 (US & Canada) 514-395-8883 (International). For questions regarding this recall call 574-372-4487.
Quantity in Commerce 105
Distribution Worldwide Distribution - US including AZ CA CO FL GA IL IN KS MD MI MN MS OH OR PA SC SD TX VA WA and WI Internationally to Canada, Australia Austria Colombia Denmark France Germany Korea New Zealand Russia South Africa and Thailand
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 = OLO and Original Applicant = ZIMMER CAS
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