EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Impl...

FDA Device Recall #Z-2591-2014 — Class II — July 2, 2014

Recall Summary

Recall Number Z-2591-2014
Classification Class II — Moderate risk
Date Initiated July 2, 2014
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Mentor Texas, LP.
Location Irving, TX
Product Type Devices
Quantity 34 units

Product Description

EN MENTOR Round High Profile Single Use Saline Breast Implant Sizer Single Use Saline Breast Implant Sizer REF 351-3380SZ 380 cc LOT 6830722. Product Usage: This product is indicated for single use for temporary insertion intraoperatively to evaluate the volume of the breast implant to be implanted.

Reason for Recall

The device labeling is stamped with 330cc and the device is actually 380cc device.

Distribution Pattern

U.S Nationwide Distribution in the states of Michigan, Maryland, Texas, New Jersey, Indiana, Nevada, Florida, California, New York, Tennessee, Pennsylvania, and Colorado.

Lot / Code Information

Part Number (PN) 351-3380SZ Lot Number 6830722

Other Recalls from Mentor Texas, LP.

Recall # Classification Product Date
Z-0367-2022 Class II MENTOR Saline-Filled Breast Implants are constr... Sep 30, 2021
Z-2070-2017 Class II Mentor Smooth Round SPECTRUM Post- Operatively... Mar 27, 2017
Z-2781-2016 Class II CPX4 Breast Tissue Expander 650 cc : Product ... Aug 9, 2016
Z-2748-2016 Class II MENTOR 2" Tall Height TE With Sutures 450cc PN:... Aug 9, 2016
Z-2747-2016 Class II MENTOR 2" Tall Height TE With Sutures 350cc PN:... Aug 9, 2016

Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.