The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1079-2019·Announced 2019-04-10

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.

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 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.
Category
Medical Device — Orthopedic Implant
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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