Zimmer GmbH Recalls Mislabeled Avenir Muller Stem Hip Implants
Zimmer GmbH is recalling 13 units of Avenir Muller Stem hip implants because size 1 stems were packaged as size 2. The recall covers distribution in Germany and Switzerland.
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, which typically indicates a situation where use of the product may cause temporary or medically reversible health consequences. The hazard is a labeling error (size mismatch) rather than a material defect or contamination, and no injuries or illnesses are reported in the source text.
Plain-English summary
Zimmer GmbH is recalling 13 units of Avenir Muller Stem Standard, uncemented HA, size 1, Taper 12/14 (Item Number: 01.06010.001). The recall is due to a labeling error where the stem inside the packaging is actually an Avenir Muller Stem size 2, despite the label indicating size 1.
The affected products were distributed internationally in Germany and Switzerland. The specific lot number is 2955599, and the UDI number is (01) 00889024479456(17)230831(10)2955599. These medical devices are intended for long-term cementless fixation of total or hemi hip arthroplasty in the femur.
Healthcare providers and patients should verify the size of the implanted stem against the packaging label. If a size 1 stem was implanted based on the packaging label, the actual size 2 stem may not fit the patient's anatomy or the intended surgical plan. Users should contact Zimmer GmbH for further instructions on how to proceed.
The recalled product
- Product
- Avenir¿ Muller Stem Standard, uncemented HA, 1, Taper 12/14 Item Number: 01.06010.001 - Product Usage: Avenir@ Muller Stems are intended to reduce pain and increase hip mobility through long term cementless fixation of total or hemi hip arthroplasty in the femur of patients with
- Manufacturer
- Zimmer GmbH
- Hazard
- Affected units
- 13
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:2955599 UDI Number:(01) 00889024479456(17)230831(10)2955599
Distribution
Distribution scope not specified by the agency.
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