The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Devices)·Z-2781-2016·Announced 2016-09-21

Mentor CPX4 Breast Tissue Expander Recall Due to Packaging Error

Mentor Texas, LP. is recalling 30 units of CPX4 Breast Tissue Expanders because they may have been packaged in the wrong box.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

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 packaging error (mis-labeling) with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Mentor Texas, LP. is recalling 30 units of CPX4 Breast Tissue Expanders (650 cc). The recall is due to a packaging error where the devices may have been placed in Artoura Tissue Expander boxes.

The affected units are from Lot 6947019. These devices are intended for temporary subcutaneous or submuscular implantation for breast reconstruction and related procedures. The recall covers distribution in the US, Germany, UK, and Belgium.

Healthcare providers and patients should verify the packaging of any CPX4 Breast Tissue Expanders in use. If the device is found in an Artoura Tissue Expander box, it should be removed and returned to the manufacturer.

The recalled product

Product
CPX4 Breast Tissue Expander 650 cc : Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an underdeveloped breast, scar revision and tissue defect procedures. The devices are intended for temporary subcutaneous or sub muscular…
Manufacturer
Mentor Texas, LP.
Category
Medical Device — Implants
Hazard
Affected units
30

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 6947019

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.

See all 2 products in this recall →

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