🔍 RecallPedia

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.

Class I - Dangerous
🏥 Medical Devices Recalled: July 2, 2014 Mentor Texas Implants & Prosthetics Nationwide

What Should You Do?

  1. Check if you have this product:
    Part Number (PN) 351-3380SZ Lot Number 6830722
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Mentor Texas, LP.
Reason for Recall:
The device labeling is stamped with 330cc and the device is actually 380cc device.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full 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.

Product Codes/Lot Numbers:

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

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: Z-2591-2014

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