Z-1470-2020Class III

NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 -

Name: Z-1470-2020 NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 -
Creator: Integra LifeSciences Corp.
Published: 2020-02-07
License: https://open.fda.gov/license/

Integra LifeSciences Corporation / initiated 2020-02-07 / Terminated / root cause: labeling and UDI

FDA source

Integra LifeSciences Corp. began a recall of NeuraGen Nerve Guide, 7mm diameter, 2cm length; Part number PNG72 - Product Usage: NeuraGen nerve guide is indicated for the repair of peripheral nerve... on 2020-02-07. FDA classified it as Class III and gives the reason as "Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1470-2020
Classification: Class III
Status: Terminated
Initiated: 2020-02-07
Posted: 2020-03-11
Terminated: 2020-06-10
Recalling firm: Integra LifeSciences Corporation
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.
Product code: JXI Cuff, Nerve
Reason for recall: Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: On February 7, 2020, the firm notified all impacted consignees by Urgent Voluntary Medical Device Recall letters. Customers were informed of the product issue. Customers were instructed to remove any affected product from service. Whether they have affected product on hand or not, customers should then fill out the acknowledgement form and return it to the recalling firm. If the customer has indicated that they have affected product on hand, Customer Service will contact them to arrange to have the product returned for a replacement or credit. Distributors were asked to remove product from further distribution and to forward recall notification to any affected customers. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 781-565-1401
Quantity in commerce: 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.
Product codes and lots: Lot # 3388360

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1470-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1470-2020	Class III	Terminated	Voluntary: Firm initiated	2020-03-18	2020-03-11

Product code JXI

K011168Class IINeurogen Nerve GuideIntegra Lifesciences Corp. / cleared 2001-06-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)