Zimmer GmbH Recalls Avenir Muller Stem Due to Potential Label Mismatch
Zimmer GmbH is recalling Avenir Muller Stems due to a potential commingle that could result in the product not matching the outer label.
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 a labeling mismatch (commingle) with no reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Zimmer GmbH is recalling a specific lot of Avenir Muller Stems (Item Number: 01.06010.104, Lot Number: 2905496). The recall is due to a potential commingle that could result in the product in the package not matching the product on the outer label.
The affected products were distributed to Belgium, Switzerland, Germany, France, the Canary Islands, Italy, and Thailand. There was no distribution to the United States.
Consumers and healthcare providers in the affected countries should contact Zimmer GmbH for further instructions regarding the return or replacement of the affected devices.
The recalled product
- Product
- Avenir Muller Stem; Item Number: 01.06010.104, Lot Number: 2905496, UDI: (01)00889024479500 (17)220430 (10)2905496
- Manufacturer
- Zimmer GmbH
- 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: 2905496
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Zimmer GmbH 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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