Conformis recalls iTotal CR Knee Replacement System model TCR-111-1111-010102 due to medial and lateral polyethylene inserts not securely fitting into the cobalt chrome tray implant.
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Conformis is recalling a specific model of knee replacement system because the plastic inserts don't fit securely into the metal tray. This could lead to complications during surgery or after implantation.
The medial and lateral polyethylene inserts are designed to fit into the cobalt chrome tray implant. If they don't secure properly, the implant may shift during use, causing pain or requiring additional surgery.
Patients who received the iTotal CR Knee Replacement System with model number TCR-111-1111-010102 are affected. Those with this specific model are at risk of complications from improper implant fit.
Check for the model number TCR-111-1111-010102 on the iTotal CR Knee Replacement System. The serial number 0450585 is also associated with this specific recall.
Identify the model number TCR-111-1111-010102 and serial number 0450585 on the knee replacement system.
No, this recall is specific to the iTotal CR Knee Replacement System model TCR-111-1111-010102.
The recall record does not specify a remedy, so contact Conformis for further instructions.
Look for the model number TCR-111-1111-010102 and serial number 0450585 on the knee replacement system.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-0672-2020 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-0672-2020 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.
