Intellijoint Navigation System recall: Software Issue
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a…
Why was Intellijoint Navigation System recalled?
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.
- Product
- Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation System is a…
- Recalling firm
- Intellijoint Surgical, Inc.
- Quantity
- N/A
- Distribution
- Worldwide distribution - US Nationwide distribution in the states of NY and CT. Country of Canada.
- Recall date
- April 1, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)