Conformis recalls iTotal CR Total Knee Replacement Systems with incorrect patient ID labels and components. This could lead to wrong patient matches during surgery. Affected units have specific model numbers and serial numbers.
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Conformis is recalling certain iTotal CR Total Knee Replacement Systems because they were prepared with incorrect patient ID labels and may contain wrong components. This could cause wrong patients to receive the wrong implants during surgery.
The kits were prepared with incorrect patient ID labels, which means the wrong patient might be matched with the wrong implant during surgery. This could lead to incorrect implant placement and potential complications for the patient.
Patients who received the recalled iTotal CR Total Knee Replacement Systems with model numbers TCR-121-1111-010102 and serial numbers 0432428 or 0432212 are affected. Surgeons and medical facilities using these specific units are at risk.
Check for model number TCR-121-1111-010102 and serial numbers 0432428 or 0432212 on the product packaging or documentation. The product is used for total knee replacements in patients with knee joint pain and disability.
Look for model number TCR-121-1111-010102 and serial numbers 0432428 or 0432212 on the product packaging or documentation.
The kits were prepared with incorrect patient ID labels and may contain incorrect components, which could lead to wrong patient matches during surgery.
Check the model number and serial numbers on the product packaging or documentation. If they match the recalled units, contact Conformis for further instructions.
The recall is due to potential incorrect patient matches during surgery, which could lead to complications. However, the hazard is not described as causing death or serious injury in normal use, so the risk level is low.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-1108-2019 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-1108-2019 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.
