Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Recalled by ConforMIS, Inc. Due to iView report displayed femoral cut measurements in the...
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
ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS 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: 1 unit
Why Was This Recalled?
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Where Was This Sold?
This product was distributed to 1 state: TX
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