Reported Apr 1, 2020 · Terminated
Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547) - Product Usage: The Intellijoint Navigation…
Intellijoint Surgical, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Intellijoint Surgical, Inc. · 60 Bathurst Dr Unit 1 · Waterloo, N/A · N/A
Is this the product you have?
- Intellijoint Navigation System, Software Application
- IJK1 (P/N 000-0547) - Product UsageThe 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
- Lot codes and dates
- Issue affects all versions of the Intellijoint KNEE Software Application in distribution. V1.2.0 and V1.2.1.
- Amount recalled
- N/A
Where it was sold
Why it was recalled
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
This product could cause temporary or reversible health problems — stop using it.
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