Conformis recalls a limited number of iTotal CR Knee Replacement System implants due to incorrect serial number labeling causing delivery to the wrong customer accounts. Affected units may need verification.
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Conformis is recalling a specific model of knee replacement implant because some units were labeled with the wrong serial number and delivered to incorrect customers. This means affected patients might receive the wrong implant kit, which could lead to improper surgical outcomes.
The hazard involves incorrect serial number labeling on tibial trays, which caused some implants to be delivered to the wrong customer accounts. This could result in patients receiving the incorrect implant kit during surgery, potentially affecting surgical outcomes.
Patients who received the iTotal CR Knee Replacement System with model number TCR-121-1111-010102 may be affected. Surgeons and hospitals that ordered this specific implant kit are most at risk of incorrect deliveries.
Check for the model number TCR-121-1111-010102 on the tibial tray. The product was sold through specific medical channels with serial numbers 0454572, 0454472, 0459726, and 0449726.
Check the model number on your tibial tray to see if it matches TCR-121-1111-010102.
Conformis recalled this specific model due to incorrect serial number labeling that caused some implants to be delivered to the wrong customer accounts.
Look for the model number TCR-121-1111-010102 on the tibial tray and check if your serial number matches 0454572, 0454472, 0459726, or 0449726.
The recall does not require immediate action, but you should verify your implant model to ensure you have the correct kit.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-1627-2020 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-1627-2020 from Conformis. 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.
