Conformis recalls iTotal Identity Posterior Stabilised Knee Replacement System model TPS-301-1113-020101 due to incorrect tibial base plate implant packaging. Affected units have specific serial numbers and UDI codes.
Incorrect tibial base plate implant packaged in kit
Conformis is recalling a specific model of knee replacement system because the kit includes an incorrect tibial base plate implant. This could lead to improper surgical fitting if used without correction.
The recall is for an incorrect tibial base plate implant packaged in the surgical kit. If used without correction, this could cause improper surgical fitting during knee replacement procedures.
Patients who received the iTotal Identity Posterior Stabilised (PS) Knee Replacement System with model number TPS-301-1113-020101 are affected. Surgeons and medical facilities using this model are most at risk.
Check for model number TPS-301-1113-020101 on the product packaging. Affected units also have serial number 0496242 and UDI code M572TPS3011113011.
Verify the model number, serial number, and UDI code on the product packaging to confirm if it is affected.
The recall is for an incorrect tibial base plate implant packaged in the kit, which could lead to improper surgical fitting if used without correction. The official notice does not specify if this causes serious injury.
Check for model number TPS-301-1113-020101, serial number 0496242, and UDI code M572TPS3011113011 on the product packaging.
The recall does not specify a remedy, so the official notice does not state what action to take.
We’ve drafted a message you can send Conformis to request your refund or repair — edit it as you like.
Subject: Recall Z-0899-2022 — Conformis Conformis Hello, I own a Conformis that is covered by recall Z-0899-2022 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.
