Conformis Recalls iTotal CR Knee Replacement System Due to Labeling Error
Conformis, Inc. is recalling four iTotal CR Knee Replacement System kits because they were labeled with incorrect serial numbers and delivered to the wrong customers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (incorrect serial numbers) resulting in delivery to the wrong customer, which fits the criteria for minor labeling errors or low-risk contamination.
Plain-English summary
Conformis, Inc. is recalling four units of the iTotal CR Knee Replacement System, Model No. TCR-121-1111-010102 (ITOTAL CR IPOLY XE IMPLANT KIT LEFT). The recall is limited to specific tibial trays that were labeled with an incorrect serial number.
The affected products were delivered to the wrong customer accounts. The distribution was limited to the states of Louisiana, New York, and Tennessee. The specific serial numbers associated with this recall are 0454572, 0454472, 0459726, and 0449726.
This recall is classified as Class II by the FDA. The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability. Consumers and healthcare providers should check their inventory for these specific serial numbers and contact Conformis, Inc. for further instructions.
The recalled product
- Product
- 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 b
- Manufacturer
- Conformis, Inc.
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 0454572 0454472 0459726 0449726
Distribution
Part of a larger recall action
This product is one of 2 recalled by Conformis, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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