FDAClass IISeptember 21, 2016

Artoura Breast Tissue Expander 700 cc Product Usage recall

Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an…

Why was Artoura Breast Tissue Expander 700 cc Product Usage recalled?

The CPX4 Tissue Expander may have been packaged in the Artoura Tissue Expander box.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 6944785

Product
Artoura Breast Tissue Expander 700 cc Product Usage: Tissue expanders can be used for breast reconstruction after mastectomy, correction of an…
Recalling firm
Mentor Texas, LP.
Quantity
48 units
Distribution
Worldwide Distribution - US Nationwide and the countries of: Germany, UK, and Belgium
Recall date
September 21, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls