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- Orthopedic Implant Recalled by Conformis, Inc. Due to Outer box labels for kit 0469247 correct, however...
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- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
Quantity: 1 kit
Why Was This Recalled?
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
Where Was This Sold?
This product was distributed to 1 state: 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