FDA Devices recall · Reported September 14, 2016
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 use beyond six months.
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Mentor Texas, LP. recalled MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with… - a moderate-severity action.
MENTOR 2" Tall Height TE With Sutures 450cc PN: 354-9313 The MENTOR CPX4 and CPX4 with… was recalled by Mentor Texas, LP. in September 14, 2016. Reason: Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc. Check the official notice for the remedy. Verify recall #Z-2748-2016 with the FDA Devices before acting.
The recall
Mentor Texas, LP. issued this moderate-severity FDA Devices recall-Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc.
- Moderate
- severity level
- 70 units
- affected scope
- Class II
- classification
- September 14, 2016
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-2748-2016 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 6 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 41,021 medical devices recalls on record
Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Product description
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 use beyond six months.
Reason for recall
Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-2748-2016 |
| Date reported | September 14, 2016 |
| Date initiated | August 9, 2016 |
| Recalling firm | Mentor Texas, LP. |
| Firm location | Irving, TX |
| Affected scope | 70 units |
| Distribution | Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand. |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-2748-2016) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
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Nationwide recalls with similar severity or category timing
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Similar severity · nearest report date
Same archive severity grade (Moderate), closest by report date among other firms and states.
Similar Medical Devices · nearest report date
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Methodology · Corrections · Archive as of August 2026