The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0658-2017·Announced 2016-12-07

ConforMIS iTotal Knee Replacement System Recalled for Incorrect Serial Number Labeling

ConforMIS is recalling two sterile iTotal Knee Replacement Systems distributed to Colorado and Nevada due to incorrect serial numbers on the F4 A/P cut guide iJig.

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 minor labeling error (incorrect serial number) with no reported injuries or illnesses, fitting the criteria for a moderate severity score.

Plain-English summary

ConforMIS, Inc. is recalling two units of the ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile, Catalog Number TCR-111-1111. The recall is due to a labeling error where the F4 A/P cut guide iJig bears an incorrect serial number. The affected units have serial numbers 0381024 and 0381042 and an expiration date of February 28, 2017.

The affected products were distributed to the states of Colorado and Nevada. The recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and patients should contact ConforMIS, Inc. for further information regarding the recall and replacement of the affected devices.

The recalled product

Product
ConforMIS iTotal Cruciate Retaining (CR) Knee Replacement System, Sterile Catalog Number: TCR-111-1111. 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.
Category
Medical Device — Orthopedic Implants
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 (2)

  • Serial Numbers: 0381024
  • 0381042 Exp Date: 2017-02-28

Distribution

Distributed in 2 states:

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