Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
iTotal CR Knee Replacement System Recalled by Conformis, Inc. Due to A limited number of tibial trays were labeled...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Conformis, Inc. directly.
Affected Products
iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT) - Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic device that treats only one or two of the three knee compartments, such as a unicondylar, patellofemoral or bicompartmental prosthesis.
Quantity: 4
Why Was This Recalled?
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Conformis, Inc.
Conformis, Inc. has 16 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report