CLASS III Device recall · Reported 18 Mar 2020 · FDA Enforcement Report

NeuraGen Nerve Guide diameter length recalled by Integra LifeSciences

Integra LifeSciences is recalling NeuraGen Nerve Guide diameter length, distributed nationwide in the US. The recall was initiated on 7 Feb 2020 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot # 3388360

Quantity recalled55

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1470-2020
FDA event ID: 84960
Recalling firm: Integra LifeSciences, Princeton, NJ
Classification: Class III
Status: Terminated
Recall initiated: 7 Feb 2020
FDA classified: 11 Mar 2020
Reported: 18 Mar 2020
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Device type: Other Medical Devices

Timeline

7 Feb 2020	Recall initiated by company
11 Mar 2020	Classified by FDA	+33 days
18 Mar 2020	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

Product as listed by the FDA

NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity.

Where it was distributed

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.

Nationwide Arizona California Colorado Indiana Louisiana Michigan Minnesota Missouri North Carolina New Mexico New York Pennsylvania South Carolina Texas

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot # 3388360

Where was it sold?

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.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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