• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Integra Dermal Regeneration TemplateTS

  • 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 2 Device Recall Integra Dermal Regeneration TemplateTS see related information
Date Initiated by Firm January 16, 2009
Date Posting Updated March 06, 2009
Recall Status1 Terminated 3 on June 25, 2009
Recall Number Z-1035-2009
Recall Event ID 50899
PMA Number P900033 
Product Classification Dermal Replacement Device - Product Code MDD
Product Integra Dermal Regeneration Template-TS
Catalog number 32021
Catalog number 82021
Code Information Lot Numbers: 105BA0134826 and 105BB0134826., Lot Numbers: 105BY0134826 and 105BW0134826.
Recalling Firm/
Integra LifeSciences Corp
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact Juith O'Grady
Manufacturer Reason
for Recall
Potential for open seals in the inner foil pouch of certain products. The outer seal remains intact and therefore the sterility of the inner pouch is maintained.
FDA Determined
Cause 2
Action Urgent: Product Recall Notification letters were sent on January 21, 1009 via Federal Express. The letter asked customers to immediately quarantine any stock on hand and contact their local Integra Sales Representative for further assistance and arrangement of product returns. The enclosed "Recall Acknowledgement and Return Form" indicating whether or not customers possess any of the affected product should also be completed and returned. Company is conducting recall to the hospital level. Questions should be directed to Judy O'Grady at 609-936-2317.
Quantity in Commerce 31 units
Distribution Nationwide Distribution -- including states of FL, CA, GA, FL, CT, MT, IL, TX, WA, TN, NC, IN, AZ, MD, CO, MO, and TN.
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.
PMA Database PMAs with Product Code = MDD and Original Applicant = Integra LifeSciences Corp.