Conformis Recalls Two iTotal Knee Replacement Systems for Labeling Errors
Conformis, Inc. is recalling two iTotal Posterior Stabilized Knee Replacement Systems because the box and sterile pouch labels did not match the contents.
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 where the packaging did not match the contents. This fits the rubric for 'Minor labeling errors' or 'voluntary precautionary recalls' where the hazard is administrative rather than a direct physical defect causing injury.
Plain-English summary
Conformis, Inc. is recalling two units of the iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102. The recall was initiated because the labeling on the boxes and sterile pouches did not match the actual contents of the packages.
The affected units, identified by Serial Numbers 0434436 and 0434836, were distributed to New Hampshire and Germany. This recall is classified as Class II by the FDA, indicating that use of the product could, in some cases, cause temporary or medically reversible health consequences.
Healthcare providers and patients who have these specific serial numbers should stop using the devices and contact Conformis, Inc. for instructions on how to return or replace the products.
The recalled product
- Product
- iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
- Manufacturer
- Conformis, Inc.
- Hazard
- 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 0434436 and 0434836
Distribution
Distributed in 1 state:
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