The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-1628-2020·Announced 2020-04-08

Conformis Recalls iTotal PS Knee Replacement System Due to Labeling Error

Conformis is recalling two iTotal PS Knee Replacement System kits because tibial trays were labeled with incorrect serial numbers and delivered to the wrong customers.

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, but the source text describes a labeling error and misdelivery without reporting any injuries, illnesses, or adverse health consequences, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Conformis, Inc. is recalling two units of the iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101 (ITOTAL PS IPOLY IMPLANT KIT LEFT). The recall is due to a labeling error where a limited number of tibial trays were labeled with an incorrect serial number.

The affected products were distributed nationwide in the United States, specifically in the states of Louisiana, New York, and Tennessee. The incorrect labeling resulted in the trays being delivered to the wrong customer accounts.

Healthcare providers and patients who have received these specific implant kits should contact Conformis, Inc. for further instructions. The recall is limited to the two units identified with the incorrect serial numbers.

The recalled product

Product
iTotal PS Knee Replacement System, Model No. TPS-111-1111-010101, (ITOTAL PS IPOLY IMPLANT KIT LEFT) Product Usage: The iTotal CR Knee Replacement System is intended for use as a total knee replacement in patients with knee joint pain and disability whose conditions cannot be…
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)

  • 0460018 0460118

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 2 recalled by Conformis, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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