ConforMIS iTotal PS Knee Implant Recalled for Software Measurement Error
ConforMIS is recalling iTotal PS Knee Replacement Kits because the iView software displayed femoral cut measurements in the wrong unit.
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 is a software measurement error (inches vs. mm) without reported injuries or illnesses, fitting the criteria for a moderate severity recall involving potential procedural errors.
Plain-English summary
ConforMIS, Inc. is recalling the ConFORMIS iTotal PS-iPoly Implant Kit-Right (Catalog Number: TPS-111-1111). The recall involves 1 unit with Serial Number 0384180, which was distributed to Texas only.
The recall was initiated because the iView report displayed femoral cut measurements in the incorrect unit of measure, specifically showing inches instead of millimeters. This software error could affect the accuracy of the surgical planning process for the total knee replacement system.
Patients who have received this specific implant should contact their healthcare provider or ConforMIS, Inc. for further instructions regarding the recall.
The recalled product
- Product
- ConFORMIS ITOTAL PS-IPOLYIMPLANT KIT-RIGHT Catalog Number:TPS-111-1111 The iTotal¿ PS Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be solely addressed by the use of a prosthetic…
- 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: 0384180
Distribution
Distributed in 1 state:
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