Mentor Breast Tissue Expanders Recalled Due to Product Mix-Up
Mentor Texas, LP. is recalling 65 units of MENTOR CPX4 breast tissue expanders because a 350cc unit was found in a carton intended for 450cc units.
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 product mix-up (wrong size) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Mentor Texas, LP. is recalling 65 units of MENTOR 2" Tall Height TE With Sutures 350cc (PN: 354-9312) breast tissue expanders. The recall was initiated because a 350cc tissue expander was found in a carton designated for the 450cc size, indicating a product mix-up.
The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy. They are intended for temporary subcutaneous or submuscular implantation and are not intended for use beyond six months. The affected units are from Lot 6981537.
The affected products were distributed worldwide, including the United States (nationwide), South Korea, Argentina, Mexico, Canada, Australia, and New Zealand. Healthcare providers and patients should verify the size of the implanted device against the packaging to ensure the correct product was used.
The recalled product
- Product
- MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation and are not intended for u
- Manufacturer
- Mentor Texas, LP.
- Hazard
- Affected units
- 65
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 6981537
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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