The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0300-2018·Announced 2018-01-10

Zimmer Biomet Recalls ECHO POR FMRL NC 9X125 Due to Labeling Error

Zimmer Biomet is recalling ECHO POR FMRL NC 9X125 medical devices because the internal patient label may be incorrect, although the outer box and product are 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, but the hazard is limited to a potential labeling error on the internal patient label while the product itself is correctly identified, fitting the criteria for minor labeling errors.

Plain-English summary

Zimmer Biomet, Inc. is recalling the ECHO POR FMRL NC 9X125, model # 192009, medical device. 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 is distributed nationwide in the US and internationally in Argentina, the Netherlands, and Canada. The specific lot number involved is 410150.

Consumers and healthcare providers should verify the identification of the device against the outer box label. If there is any uncertainty regarding the internal patient label, they should contact Zimmer Biomet for further instructions.

The recalled product

Product
ECHO POR FMRL NC 9X125, model # 192009
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: 410150

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 →

Related recalls

Same manufacturer · Zimmer Biomet, Inc.

See all →

Same hazard · mis labeling

See all →

Similar recalls