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U.S. Department of Health and Human Services

Class 3 Device Recall

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  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/
Manufacturer		 Integra LifeSciences Corp
105 Morgan Ln
Plainsboro NJ 08536-3339
For Additional Information Contact Thomas Tarca
609-275-0500
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.
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