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

Class 3 Device Recall

  • 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 see related information
Date Initiated by Firm July 02, 2008
Date Posted September 20, 2008
Recall Status1 Terminated 3 on September 22, 2008
Recall Number Z-2328-2008
Recall Event ID 48964
PMA Number P900033 
Product Classification Device, Dermal Replacement - Product Code MDD
Product Integra Dermal Regeneration Template; 8 x 10 in (20 cm x 25 cm) , Sterile;
Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536 USA
Code Information Catalog Number 38101, Lot Number 105BA0121823
Recalling Firm/
Integra LifeSciences Corp
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact Thomas Tarca
Manufacturer Reason
for Recall
Product labeled with an expiration date on May 2010, while the actual expiration date should be April 2010.
FDA Determined
Cause 2
Labeling mix-ups
Action The firm issued a letter titled URGENT-RECALL NOTICE to Integra Sales Reps on July 2, 2008. Contact Integra at 609-799-3297 if you have questions.
Quantity in Commerce 10 units
Distribution Product was distributed to 5 hospitals in TN, CA, NY, IN and AL.
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.