Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System Recalled by ConforMIS, Inc. Due to Mislabeling
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 Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.
Quantity: 2 units
Why Was This Recalled?
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Where Was This Sold?
This product was distributed to 2 states: CO, NV
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