RecallRadar

FDA Device recall Z-1470-2020

NeuraGen Nerve Guide, 7mm diameter, 2cm length

On 2020-03-18 the FDA classified a Class III recall of NeuraGen Nerve Guide, 7mm diameter, 2cm length by Integra Lifesciences, citing nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1470-2020
ClassificationClass III
Statusterminated
Initiated2020-02-07
Published2020-03-18
Last updated2026-09-13 11:55 UTC
CompanyIntegra Lifesciences
DistributionUS

Product

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.

Reason

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

Identifiers

code_infoLot # 3388360

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1470-2020%22

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