Integra LifeSciences Corp. 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. Recall

Check Your Product

According to the U.S. Food and Drug Administration (FDA)

Reason for Recall

As stated by FDA

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

Recommended Action

Per FDA guidance

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: custsvcnj@integralife.com Outside USA: 781-565-1401