Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall NeuraGen Nerve Guide

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall NeuraGen Nerve Guide see related information
Date Initiated by Firm February 07, 2020
Create Date March 11, 2020
Recall Status1 Terminated 3 on June 10, 2020
Recall Number Z-1470-2020
Recall Event ID 84960
510(K)Number K011168  
Product Classification Cuff, nerve - Product Code JXI
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.
Code Information Lot # 3388360
Recalling Firm/
Manufacturer		 Integra LifeSciences Corp.
1100 Campus Rd
Princeton NJ 08540-6650
For Additional Information Contact Dr. Patricia Kihn
717-309-3966
Manufacturer Reason
for Recall		 Nonconforming product which was dispositioned for rejection was mistakenly released for commercial use.
FDA Determined
Cause 2		 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: custsvcnj@integralife.com 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = JXI and Original Applicant = INTEGRA LIFESCIENCES CORP.
-
-