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
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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
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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 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 |
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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 = OLO
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