Conformis iTotal CR G2 Knee Replacement System Recalled for Incorrect Serial Numbers
ConforMIS, Inc. is recalling one unit of the iTotal CR G2 Knee Replacement System due to an incorrect serial number on the tibial insert packaging.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 the hazard involves a potential fit issue with the device components, which is a moderate risk without reported injuries.
Plain-English summary
ConforMIS, Inc. is recalling one unit of the Conformis iTotal CR G2 Knee Replacement System, catalog/model number M57250600010. The device is intended for use as a total knee replacement in patients with knee joint pain and disability.
The recall was initiated because the tibial inserts packaged in the tray have an incorrect serial number. This discrepancy may result in the inserts not fitting properly during the procedure. The affected unit, serial number 0340552, was distributed to Indiana.
Consumers and healthcare providers should stop using the affected product and contact ConforMIS, Inc. for further instructions or a replacement.
The recalled product
- Product
- 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.
- Manufacturer
- ConforMIS, Inc.
- Hazard
- Affected units
- 1
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)
- Serial Number: 0340552
Distribution
Distributed in 1 state:
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