Mentor Artoura Breast Tissue Expander Recall for Packaging Error
Mentor Texas, LP. is recalling 48 Artoura Breast Tissue Expanders because CPX4 devices may have been packaged in Artoura boxes.
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 reasonable probability of temporary or medically reversible health consequences. The hazard is a packaging error (mis-labeling) rather than a direct structural defect or contamination, fitting the Moderate severity criteria for labeling errors.
Plain-English summary
Mentor Texas, LP. is recalling 48 units of the Artoura Breast Tissue Expander 700 cc. The recall is due to a packaging error where the CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.
The affected devices are intended for temporary subcutaneous or submuscular implantation for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision, and tissue defect procedures. The devices are not intended for use beyond six months.
The recall covers Lot 6944785. Distribution was worldwide, including the United States, Germany, the UK, and Belgium. Consumers and healthcare providers should check their inventory for this specific lot number and packaging discrepancy.
The recalled product
- Product
- Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscula
- Manufacturer
- Mentor Texas, LP.
- Affected units
- 48
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 6944785
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Mentor Texas, LP. 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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