Conformis recalls iTotal CR knee implants with incorrect box contents. Check serial number 0469247 (exp 2021-01-31) for affected units. No immediate action needed.
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Conformis is recalling a specific knee replacement implant kit due to a mix-up in the box contents. This means some customers might receive the wrong implant components, which could lead to improper surgical procedures.
The recall is caused by a mix-up in the box contents. The outer labels for kit 0469247 correctly state the product, but the boxes actually contain the implants and jigs for a different kit (0468920). This could lead to using the wrong components during surgery.
Patients who received the Conformis iTotal CR knee implant kit with serial number 0469247 (expiring January 31, 2021) are affected. Surgeons using this specific kit during procedures are at higher risk.
Check for the serial number 0469247 on the implant kit box. The expiration date is January 31, 2021. This specific kit was sold with the product name 'ITOTAL CR IPOLY XE IMPLANT KIT LEFT'.
Look for the serial number 0469247 on the implant kit box.
The recall is for a label mix-up in the box contents, not a safety hazard. No immediate action is needed.
Check the serial number on the box. If it's 0469247 (expiring January 31, 2021), contact Conformis for details.
The affected kit has the serial number 0469247 and expires January 31, 2021. It's labeled as 'ITOTAL CR IPOLY XE IMPLANT KIT LEFT'.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-2849-2020 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-2849-2020 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.
