Intellijoint Navigation System Software Recalled for Incorrect Knee Surgery Calculations
Intellijoint Surgical is recalling its Navigation System software because it may incorrectly calculate femur resection depth during total knee arthroplasty.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device software defect that could lead to incorrect surgical measurements, representing a risk of harm where injury has not yet been reported, which aligns with the 'High' severity criteria.
Plain-English summary
Intellijoint Surgical, Inc. is recalling the Intellijoint Navigation System, Software Application, IJK1 (P/N 000-0547). The recall affects all versions of the Intellijoint KNEE Software Application in distribution, specifically versions V1.2.0 and V1.2.1.
The software is a computer-controlled optical localizer intended to provide intra-operative measurements to surgeons to aid in the selection and positioning of orthopedic implant system components. The recall is being issued because, during total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
The product was distributed worldwide, including nationwide distribution in the United States in the states of New York and Connecticut, as well as in Canada. No specific number of affected units or reported injuries is provided in the source text.
The recalled product
- 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…
- Manufacturer
- Intellijoint Surgical, Inc.
Distribution
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