FDAClass IISeptember 14, 2016

MENTOR 2" Tall Height TE With Sutures 350cc PN recall

MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast…

Why was MENTOR 2" Tall Height TE With Sutures 350cc PN recalled?

Tissue expander product mix found: CPX4 350cc was placed in a carton for the CPX4 450cc

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 6981537

Product
MENTOR 2" Tall Height TE With Sutures 350cc PN: 354-9312 The MENTOR CPX4 and CPX4 with Suture Tabs Breast Tissue Expanders are used for breast…
Recalling firm
Mentor Texas, LP.
Quantity
65 units
Distribution
Worldwide Distribution: US (nationwide) and countries of: South Korea, Argentina, Mexico, Canada, Australia and New Zealand.
Recall date
September 14, 2016
Classification
Class II
Status
Terminated
Agency
FDA (device)
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