Recall Z-1470-2020 ยท JXI Cuff, Nerve
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.
| Date | Feb 7, 2020 |
| Status | Terminated |
| Reason | Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use. |
| 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 fu |
| 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011168 | NEUROGEN NERVE GUIDE Integra Lifesciences Corp., Jun 22, 2001 |