Agency classClass IIOur severity:Moderate FDA (Devices)·Z-0303-2018·Announced 2018-01-10

Zimmer Biomet Recalls OSS Cemented IM Stem Due to Labeling Error

Zimmer Biomet is recalling specific OSS Cemented IM Stem units because the internal patient label may be incorrect, although the outer box and product itself 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 without reported injuries or illnesses, fitting the criteria for moderate severity associated with minor labeling errors or low-risk issues.

Plain-English summary

Zimmer Biomet, Inc. is recalling the OSS CEMENTED IM STEM 12X150, model # 150366, under FDA recall number Z-0303-2018. The recall is limited to units with Lot Number 71180. The issue involves a potential labeling error where the patient label inside the product box may be incorrect. The source text confirms that the outer box label and the actual product are correctly identified.

The affected devices were distributed nationwide in the United States, as well as internationally in Argentina, the Netherlands, and Canada. This recall is classified as Class II by the FDA. The source text does not report any illnesses, injuries, or deaths associated with this labeling error.

Healthcare providers and patients should verify the product identification against the outer box label to ensure the correct device is used. Since the internal patient label may be inaccurate, reliance on the outer box and product identification is necessary to avoid potential mix-ups.

The recalled product

Product: OSS CEMENTED IM STEM 12X150, model # 150366
Manufacturer: Zimmer Biomet, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling

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: 71180

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 →

Same manufacturer · Zimmer Biomet, Inc.

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Same hazard · mis labeling