The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-0298-2018·Announced 2018-01-10

Zimmer Biomet Recalls Hip Fracture Stem Due to Internal Label Error

Zimmer Biomet is recalling specific hip fracture stems 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 and involves a labeling error where the outer box and product are correct, fitting the criteria for minor labeling errors or low-risk issues.

Plain-English summary

Zimmer Biomet, Inc. is recalling the COMP 12MM HUM FRAC STEM MACRO, model # 11-113562, lot number 529890. 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 products were distributed nationwide in the US and internationally in Argentina, the Netherlands, and Canada. This recall is classified as Class II by the U.S. Food and Drug Administration.

Healthcare providers and patients should verify the product identification against the outer box label. If there is any discrepancy or uncertainty regarding the internal patient label, contact Zimmer Biomet for further instructions.

The recalled product

Product
COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
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: 529890

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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