Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Conformis iTotal CR G2 Knee Replacement System Catalog/Model #: M57250600010 Recalled by ConforMIS, Inc. Due to Incorrect serial number of tibial inserts packaged in...
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 CR G2 Knee Replacement System Catalog/Model #: M57250600010 Intended for use as a total knee replacement in patients with knee joint pain and disability.
Quantity: 1 unit
Why Was This Recalled?
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Where Was This Sold?
This product was distributed to 1 state: IN
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