Mentor CPX4 Breast Tissue Expander Recall Due to Packaging Error
Mentor Texas, LP. is recalling 30 units of CPX4 Breast Tissue Expanders because they may have been packaged in the wrong box.
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 packaging error (mis-labeling) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Mentor Texas, LP. is recalling 30 units of CPX4 Breast Tissue Expanders (650 cc). The recall is due to a packaging error where the devices may have been placed in Artoura Tissue Expander boxes.
The affected units are from Lot 6947019. These devices are intended for temporary subcutaneous or submuscular implantation for breast reconstruction and related procedures. The recall covers distribution in the US, Germany, UK, and Belgium.
Healthcare providers and patients should verify the packaging of any CPX4 Breast Tissue Expanders in use. If the device is found in an Artoura Tissue Expander box, it should be removed and returned to the manufacturer.
The recalled product
- Product
- CPX4 Breast Tissue Expander 650 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 muscular
- Manufacturer
- Mentor Texas, LP.
- Category
- Medical Device — Implants
- Hazard
- Affected units
- 30
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 6947019
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.
See all 2 products in this recall →Related recalls
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