The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0305-2018·Announced 2018-01-10

Zimmer Biomet Recalls Distal Femoral Knee Implant Due to Labeling Error

Zimmer Biomet is recalling a specific lot of distal femoral knee implant assemblies because the internal patient label may be incorrect, although the product itself is correctly identified.

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 product itself is correctly identified, fitting the criteria for minor labeling errors or low-risk contamination.

Plain-English summary

Zimmer Biomet, Inc. is recalling the RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828, lot number 856550. The recall is due to a possibility that the patient label inside the product box was incorrectly labeled. The outer box label and the actual product are correctly identified, but the internal patient label could be incorrect.

The affected product was distributed nationwide in the United States and internationally in Argentina, the Netherlands, and Canada. This is a Class II recall, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

Healthcare providers and patients should verify the product identification against the outer box label and the actual product to ensure the correct implant is used. If the internal patient label is found to be incorrect, the product should not be used until the discrepancy is resolved.

The recalled product

Product
RED SEXP DSTL FEM 19CM LT ASSY, model # CP111828
Manufacturer
Zimmer Biomet, Inc.
Category
Medical Device — Orthopedic Implant
Hazard

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)

  • Lot Number: 856550

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 10 recalled by Zimmer Biomet, 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 10 products in this recall →

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