Zimmer GmbH Recalls Avenir Muller Stem Due to Potential Label Mismatch
Zimmer GmbH is recalling specific Avenir Muller Stem implants because a potential commingle may cause the product in the package to not match the outer label.
What this means for you
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. The hazard is a labeling mismatch (commingle) which is a significant quality issue but does not involve a direct physical defect or reported injuries, fitting the Moderate criteria for labeling errors.
Plain-English summary
Zimmer GmbH is recalling the Avenir Muller Stem, Item Number 01.06010.003, Lot Number 2904368. The recall is due to a potential commingle that could result in the product inside the package not matching the product identified on the outer label.
The source text states that there was no distribution of these products to the United States. The affected units were distributed to Belgium, Switzerland, Germany, France, the Canary Islands, Italy, and Thailand.
Consumers in the United States are not affected by this recall. Healthcare providers and patients in the affected countries should contact Zimmer GmbH for further instructions regarding the specific lot number.
The recalled product
- Product
- Avenir Muller Stem; Item Number: 01.06010.003, Lot Number: 2904368, UDI: (01) 00889024479494 (17) 220331 (10) 2904368
- 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: 2904368
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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