Conformis Recalls Two iTotal CR Total Knee Replacement Systems
Conformis, Inc. is recalling two iTotal CR Total Knee Replacement Systems prepared with incorrect patient ID labels and potentially incorrect components.
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 incorrect labeling and potential component errors without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Conformis, Inc. is recalling two units of the iTotal CR Total Knee Replacement System, Catalog No. TCR-1111, Model No. TCR-121-1111-010102 and M5725INT0600010. The affected units have serial numbers 0432428 and 0432212. These devices are intended for use as total knee replacements in patients with knee joint pain and disability.
The recall was initiated because the kits were prepared with incorrect patient ID labels and may contain incorrect components. The agency has classified this as a Class II recall. The affected units were distributed worldwide, specifically in North Carolina, USA, and Hungary.
Healthcare providers and patients should verify the serial numbers of their devices against the recall notice. If a device matches the affected serial numbers, it should not be used. Patients who have already received the implant should contact their healthcare provider for further instructions.
The recalled product
- Product
- iTotal CR Total Knee Replacement System, TCR-121-1111 (Catalog No.) / TCR-121-1111-010102 (Model No.) M5725INT0600010 (Model No.) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and…
- Manufacturer
- Conformis, Inc.
- Affected units
- 2
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 Numbers 0432428 and 0432212
Distribution
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