Class 3 Device Recall

• Date Initiated by Firm: July 02, 2008
• Date Posted: September 20, 2008
• Recall Status: Terminated 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
• FEI Number: 1121308
• 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: 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