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U.S. Department of Health and Human Services

Class 2 Device Recall Intellijoint Navigation System

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  Class 2 Device Recall Intellijoint Navigation System see related information
Date Initiated by Firm February 11, 2020
Create Date March 23, 2020
Recall Status1 Terminated 3 on June 10, 2020
Recall Number Z-1559-2020
Recall Event ID 85016
510(K)Number K191507  
Product Classification Orthopedic stereotaxic instrument - Product Code OLO
Product Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a computer-controlled, optical localizer intended to provide intra-operative measurements to a surgeon to aid in selection and positioning of orthopedic implant system components, where a reference to a rigid anatomical structure can be identified.
Code Information Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.
Recalling Firm/
Manufacturer		 Intellijoint Surgical, Inc.
60 Bathurst Dr Unit 1
Waterloo Canada
Manufacturer Reason
for Recall		 During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
FDA Determined
Cause 2		 Software design
Action The firm notified the Intellijoint Surgical Sales Representatives that manage the affected sites. Communications were sent via email on 2/11/2020. Sales reps are responsible for verbally communicating the correction to affected users within their respective service areas. Users were to be advised of the following: (1) Until a Software update is provided, users should consult the Instructions for Use (Section 6.9.4  Lateral Femoral Condyle Definition (pg. 42) and Section 6.9.5  Medial Femoral Condyle Definition (pg. 42)) and follow the steps outlined for the acquisition of data used to calculate resection depth. (2) Resection depth should be verified by manual methods (calipers, angel wings etc.) for each case. (3) Due to the low risk and nature of the error, Intellijoint is not requesting that affected product be returned unless requested by the customer. Should the customer/user wish to return affected devices, please contact Sankavi Muralitharan (s.muralitharan@intellijointsurgical.com) or Breanne Cuddington, Senior Regulatory Affairs Associate, at b.cuddington@intellijointsurgical.com; 1-888-232-2634 ex. 2234. A software update is under development to correct for this error. The expected release date for the update is February 29, 2020, at which time Intellijoint Sales Representatives will update all affected systems with the new software by March 30, 2020.
Distribution Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.
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 = Intellijoint Surgical Inc.
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