Zimmer Biomet Recalls COMP Primary Stem Due to Labeling Error
Zimmer Biomet is recalling COMP Primary Stem 8MM MINI devices 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 issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling the COMP PRIMARY STEM 8MM MINI, model # 113628, due to a potential labeling error. The recall is limited to Lot Number 523080. The issue involves the possibility that the patient label inside the product box was incorrectly labeled.
The outer box label and the actual product are correctly identified. However, the internal patient label could be incorrect. This recall is classified as Class II by the U.S. Food and Drug Administration.
The affected devices were distributed nationwide in the US and internationally in Argentina, the Netherlands, and Canada. Consumers and healthcare providers should verify the lot number of their devices and contact Zimmer Biomet for further instructions.
The recalled product
- Product
- COMP PRIMARY STEM 8MM MINI, model # 113628
- Manufacturer
- Zimmer Biomet, Inc.
- 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: 523080
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.
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