| Class 2 Device Recall Navitrack System OS Knee Universal, Stereotaxic instrument | |
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
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = HAW
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