Conformis iTotal Knee Implant Kit Recalled for Incorrect Contents
Conformis, Inc. is recalling one iTotal CR Knee Replacement kit because the box contained implants and jigs for a different serial number.
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. The hazard is a labeling/packaging error where the box contents did not match the label, which is a moderate risk of using the wrong implant but does not involve a known defect in the implant material itself or reported injuries.
Plain-English summary
Conformis, Inc. is recalling one kit of the iTotal Cruciate Retaining (CR) Knee Replacement System, specifically the ITOTAL CR IPOLY XE IMPLANT KIT LEFT (Cat: TCR-121-1111-010102). The affected unit has Serial Number 0469247 and an expiration date of 2021-01-31.
The recall was initiated because, although the outer box labels for kit 0469247 were correct, the boxes actually contained the implants and jigs intended for kit 0468920. This discrepancy means the physical contents did not match the labeled serial number.
The distribution pattern is listed as NV. Consumers and healthcare providers should verify the serial numbers of their inventory against the recall notice. If the affected kit is found, it should be removed from use and returned to the manufacturer or the appropriate regulatory authority.
The recalled product
- Product
- Conformis iTotal Cruciate Retaining (CR) Knee Replacement System- Orthopedic Implant Cat: TCR-121-1111-010102, (ITOTAL CR IPOLY XE IMPLANT KIT LEFT)
- Manufacturer
- Conformis, Inc.
- 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: 0469247 Exp. 2021-01-31
Distribution
Distributed in 1 state:
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