Zimmer Biomet Recalls Lateral Troch Plate Due to Labeling Error
Zimmer Biomet is recalling Lateral Troch Plate Full Crimp 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 or low-risk issues.
Plain-English summary
Zimmer Biomet, Inc. is recalling the Lateral Troch Plate Full Crimp - 254mm, model # 350838, lot number 406590. 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 devices were distributed nationwide in the US and internationally in Argentina, the Netherlands, and Canada. The source text does not specify the number of units affected or the specific dates of distribution.
Consumers and healthcare providers should contact Zimmer Biomet for further instructions regarding the recall. The source text does not provide specific contact details or instructions for return or replacement.
The recalled product
- Product
- Lateral Troch Plate Full Crimp - 254mm, model # 350838
- 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: 406590
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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