FDAClass IIMay 17, 2017

Mentor Smooth Round SPECTRUM Post- Operatively recall

Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048

Why was Mentor Smooth Round SPECTRUM Post- Operatively recalled?

Missing Dome Pack accessory.

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 Number: 7377332

Product
Mentor Smooth Round SPECTRUM Post- Operatively Adjustable Saline Breast Implant, Product Code: 350-1490, UDI/GTIN: 00081317002048
Recalling firm
Mentor Texas, LP.
Quantity
28 units
Distribution
US Distribution to the states of : MI, CA, CT, IL, IN, NY, NC, OH and OK.
Recall date
May 17, 2017
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls