Intellijoint recalls its Navigation System software (V1.2.0/V1.2.1) due to potential incorrect femur depth calculations during knee surgery. Affected devices may require correction to prevent surgical errors.
During total knee arthroplasty (TKA), the software may incorrectly calculate femur resection depth.
Intellijoint's knee surgery navigation software (versions 1.2.0 and 1.:2.1) is recalled because it may calculate incorrect femur resection depth during knee replacement surgery. This could lead to improper implant placement and surgical complications.
The software may incorrectly calculate how deep the femur should be resected during knee replacement surgery. This could result in improper implant placement, potentially causing surgical complications or requiring additional procedures.
Surgeons using Intellijoint Navigation System software versions 1.2.0 and 1.2.1 for total knee replacements are affected. Patients undergoing knee surgery with these software versions face the highest risk.
Check if you have the Intellijoint Navigation System software version 1.2.0 or 1.2.1. The product was distributed for total knee arthroplasty procedures.
Verify your software version by checking the product documentation or software settings.
The recall states the software may incorrectly calculate femur resection depth during knee surgery, which could lead to improper implant placement. However, the exact risk level is not specified in the notice.
The recall does not specify a remedy, so no action is required at this time. Contact Intellijoint Surgical for further guidance.
Check for software versions 1.2.0 or 1.2.1 in the Intellijoint Navigation System documentation or settings.
We’ve drafted a message you can send Intellijoint to request your refund or repair — edit it as you like.
Subject: Recall Z-1559-2020 — Intellijoint Intellijoint Hello, I own a Intellijoint that is covered by recall Z-1559-2020 from Intellijoint. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
