FDAClass IIIMarch 18, 2020

NeuraGen Nerve Guide recall

NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral…

Why was NeuraGen Nerve Guide recalled?

Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.

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 # 3388360

Product
NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral…
Recalling firm
Integra LifeSciences Corp.
Quantity
55
Distribution
Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, IN, LA, MI, MN, MO, NC, NM, NY, PA, SC, and TX and countries of Italy, France, Germany, and Finland.
Recall date
March 18, 2020
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls