Mentor CPX4 Breast Tissue Expanders Recalled for Product Mix-Up
Mentor Texas, LP. is recalling 70 units of CPX4 breast tissue expanders because a 350cc product was found in a carton labeled for the 450cc version.
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, but the source text describes a labeling/packaging mix-up without reporting any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Mentor Texas, LP. is recalling 70 units of MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders. The recall is due to a product mix-up where a CPX4 350cc tissue expander was found in a carton intended for the CPX4 450cc model. The affected product is identified by Lot 6981543 and Product Number 354-9313.
These breast tissue expanders are used for breast reconstruction following mastectomy and are intended for temporary subcutaneous or submuscular implantation. They are not intended for use beyond six months. The affected units were distributed nationwide in the United States and in South Korea, Argentina, Mexico, Canada, Australia, and New Zealand.
Healthcare providers and patients should check their inventory and records for Lot 6981543. If the product is in use, providers should contact Mentor Texas, LP. for instructions on replacement or return. Patients who have had these devices implanted should consult their surgeon regarding the specific product details.
The recalled product
- Product
- MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 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.
- Affected units
- 70
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 6981543
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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